Charles R. V. Tomson
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Charles R. V. Tomson has a total of 940 co-authors. Here are the top co-authors by number of shared publications:
- David Ansell
Quintile IMS, London, UK
29 shared publications Paul Roderick
Richard Bright Renal Service, North Bristol NHS Trust, Bristol, UK
20 shared publicationsRommel Ravanan
Richard Bright Renal Unit, Southmead Hospital, Bristol, United Kingdom
14 shared publications- Yoav Ben-Shlomo
Population Health Sciences, University of Bristol, Bristol, UK
13 shared publications Wendy Metcalfe
Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
12 shared publicationsAnna Casula
UK Renal Registry, Bristol, UK
11 shared publications
Latest Publications
- 4 October 2023
- Published by Springer Nature
- p. 403-423
Nephrolithiasis and Nephrocalcinosis
- Open Access
- 13 September 2023
- Published by Oxford University Press (OUP) in Clinical Kidney Journal
- Vol. 16 (Supplement) , i12-i19
Shared decision making: a personal view from two kidney doctors and a patient
Shared decision making (SDM) combines the clinician's expertise in the treatment of disease with the patient's expertise in their lived experience and what is important to them. All decisions made in the care of patients with kidney disease can potentially be explored through SDM. Adoption of SDM in routine kidney care faces numerous institutional and practical barriers. Patients with chronic disease who have become accustomed to paternalistic care may need support to engage in SDM—even though most patients actively want more involvement in decisions about their care. Nephrologists often underestimate the risks and overestimate the benefits of investigations and treatments and often default to recommending burdensome treatments rather than discussing prognosis openly. Guideline bodies continue to issue recommendations written for healthcare professionals without providing patient decision aids. To mitigate health inequalities, care needs to be taken to provide SDM to all patients, not just the highly health-literate patients least likely to need additional support in decision making. Kidney doctors spend much of their time in the consulting room, and it is unjustifiable that so little attention is paid to the teaching, audit and maintenance of consultation skills. Writing letters to the patient to summarise the consultation rather than sending them a copy of a letter between health professionals sets the tone for a consultation in which the patient is an active partner. Adoption of SDM will require nephrologists to relinquish long-established paternalistic models of care and restructure care around the values and preferences of patients.
- 13 September 2023
- Published by Oxford University Press (OUP) in Clinical Kidney Journal
- Vol. 16 (Supplement) , i12-i19
Open AccessShared decision making: a personal view from two kidney doctors and a patient
Shared decision making (SDM) combines the clinician's expertise in the treatment of disease with the patient's expertise in their lived experience and what is important to them. All decisions made in the care of patients with kidney disease can potentially be explored through SDM. Adoption of SDM in routine kidney care faces numerous institutional and practical barriers. Patients with chronic disease who have become accustomed to paternalistic care may need support to engage in SDM—even though most patients actively want more involvement in decisions about their care. Nephrologists often underestimate the risks and overestimate the benefits of investigations and treatments and often default to recommending burdensome treatments rather than discussing prognosis openly. Guideline bodies continue to issue recommendations written for healthcare professionals without providing patient decision aids. To mitigate health inequalities, care needs to be taken to provide SDM to all patients, not just the highly health-literate patients least likely to need additional support in decision making. Kidney doctors spend much of their time in the consulting room, and it is unjustifiable that so little attention is paid to the teaching, audit and maintenance of consultation skills. Writing letters to the patient to summarise the consultation rather than sending them a copy of a letter between health professionals sets the tone for a consultation in which the patient is an active partner. Adoption of SDM will require nephrologists to relinquish long-established paternalistic models of care and restructure care around the values and preferences of patients.
- 28 May 2022
- Published by Springer Nature
- p. 1135-1147
Chronic Kidney Disease: Diagnosis and Assessment
- Open Access
- 7 December 2021
- Published by Oxford University Press (OUP) in Cardiovascular Research
- Vol. 119 (1) , 213-220
High-dose intravenous iron reduces myocardial infarction in patients on haemodialysis
To investigate the effect of high-dose iron vs. low-dose intravenous (IV) iron on myocardial infarction (MI) in patients on maintenance haemodialysis. This was a pre-specified analysis of secondary endpoints of the Proactive IV Iron Therapy in Hemodialysis Patients trial (PIVOTAL) randomized, controlled clinical trial. Adults who had started haemodialysis within the previous year, who had a ferritin concentration P = 0.01] and non-fatal MI (HR 0.69, 95% CI 0.51–0.93; P = 0.01) when compared with reactive low-dose IV iron. There was less effect of high-dose IV iron on recurrent MI events than on the time-to-first event analysis. In total, 8.4% of patients on maintenance haemodialysis had an MI over 2 years. High-dose compared to low-dose IV iron reduced MI in patients receiving haemodialysis. 2013-002267-25.
- 7 December 2021
- Published by Oxford University Press (OUP) in Cardiovascular Research
- Vol. 119 (1) , 213-220
Open AccessHigh-dose intravenous iron reduces myocardial infarction in patients on haemodialysis
To investigate the effect of high-dose iron vs. low-dose intravenous (IV) iron on myocardial infarction (MI) in patients on maintenance haemodialysis. This was a pre-specified analysis of secondary endpoints of the Proactive IV Iron Therapy in Hemodialysis Patients trial (PIVOTAL) randomized, controlled clinical trial. Adults who had started haemodialysis within the previous year, who had a ferritin concentration P = 0.01] and non-fatal MI (HR 0.69, 95% CI 0.51–0.93; P = 0.01) when compared with reactive low-dose IV iron. There was less effect of high-dose IV iron on recurrent MI events than on the time-to-first event analysis. In total, 8.4% of patients on maintenance haemodialysis had an MI over 2 years. High-dose compared to low-dose IV iron reduced MI in patients receiving haemodialysis. 2013-002267-25.
- 25 November 2021
- Published by Wolters Kluwer Health in Kidney360
- Vol. 2 (11) , 1761-1769
Stroke in Hemodialysis Patients Randomized to Different Intravenous Iron Strategies: A Prespecified Analysis from the PIVOTAL Trial
Key Points: In analysis of the PIVOTAL trial, proactive intravenous iron dosing was not associated with increased stroke risk in patients on hemodialysis. Risk factors for stroke included diabetes, prior stroke, higher BP, lower serum albumin, inflammation, and women. Mortality of stroke was high; 58% of patients with a stroke event died during follow-up compared with 23% without a stroke. Background: People with kidney failure treated with hemodialysis (HD) are at increased risk of stroke compared with similarly aged people with normal kidney function. One concern is that treatment of renal anemia might increase stroke risk. We studied risk factors for stroke in a prespecified secondary analysis of a randomized, controlled trial of intravenous iron treatment strategies in HD. Methods: We analyzed data from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial, focusing on variables associated with risk of stroke. The trial randomized 2141 adults who had started HD P=0.66). In multivariable models, women, diabetes, history of prior stroke at baseline, higher baseline systolic BP, lower serum albumin, and higher C-reactive protein were independently associated with stroke events during follow-up. Hemoglobin, total iron, and ESA dose were not associated with risk of stroke. Fifty-eight percent of patients with a stroke event died during follow-up compared with 23% without a stroke. Conclusions: In patients on HD, stroke risk is broadly associated with risk factors previously described to increase cardiovascular risk in this population. Proactive intravenous iron does not increase stroke risk. Clinical Trial registry name and registration number: Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL), 2013-002267-25
- 25 November 2021
- Published by Wolters Kluwer Health in Kidney360
- Vol. 2 (11) , 1761-1769
Stroke in Hemodialysis Patients Randomized to Different Intravenous Iron Strategies: A Prespecified Analysis from the PIVOTAL Trial
Key Points: In analysis of the PIVOTAL trial, proactive intravenous iron dosing was not associated with increased stroke risk in patients on hemodialysis. Risk factors for stroke included diabetes, prior stroke, higher BP, lower serum albumin, inflammation, and women. Mortality of stroke was high; 58% of patients with a stroke event died during follow-up compared with 23% without a stroke. Background: People with kidney failure treated with hemodialysis (HD) are at increased risk of stroke compared with similarly aged people with normal kidney function. One concern is that treatment of renal anemia might increase stroke risk. We studied risk factors for stroke in a prespecified secondary analysis of a randomized, controlled trial of intravenous iron treatment strategies in HD. Methods: We analyzed data from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial, focusing on variables associated with risk of stroke. The trial randomized 2141 adults who had started HD P=0.66). In multivariable models, women, diabetes, history of prior stroke at baseline, higher baseline systolic BP, lower serum albumin, and higher C-reactive protein were independently associated with stroke events during follow-up. Hemoglobin, total iron, and ESA dose were not associated with risk of stroke. Fifty-eight percent of patients with a stroke event died during follow-up compared with 23% without a stroke. Conclusions: In patients on HD, stroke risk is broadly associated with risk factors previously described to increase cardiovascular risk in this population. Proactive intravenous iron does not increase stroke risk. Clinical Trial registry name and registration number: Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL), 2013-002267-25
- Open Access
- 1 September 2021
- Published by American College of Physicians in Annals of Internal Medicine
- Vol. 174 (9) , 1270-1281
Management of Blood Pressure in Patients With Chronic Kidney Disease Not Receiving Dialysis: Synopsis of the 2021 KDIGO Clinical Practice Guideline
This synopsis of the Kidney Disease: Improving Global Outcomes clinical practice guideline on the management of blood pressure in patients with chronic kidney disease (CKD) not receiving dialysis s... Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2021 clinical practice guideline for the management of blood pressure (BP) in patients with chronic kidney disease (CKD) not recei...
- 1 September 2021
- Published by American College of Physicians in Annals of Internal Medicine
- Vol. 174 (9) , 1270-1281
Open AccessManagement of Blood Pressure in Patients With Chronic Kidney Disease Not Receiving Dialysis: Synopsis of the 2021 KDIGO Clinical Practice Guideline
This synopsis of the Kidney Disease: Improving Global Outcomes clinical practice guideline on the management of blood pressure in patients with chronic kidney disease (CKD) not receiving dialysis s... Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2021 clinical practice guideline for the management of blood pressure (BP) in patients with chronic kidney disease (CKD) not recei...
- Open Access
- 21 November 2020
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 9 (11) , 3751
Investigating Ethnic Disparity in Living-Donor Kidney Transplantation in the UK: Patient-Identified Reasons for Non-Donation among Family Members
There is ethnic inequity in access to living-donor kidney transplants in the UK. This study asked kidney patients from Black, Asian and minority ethnic groups why members of their family were not able to be living kidney donors. Responses were compared with responses from White individuals. This questionnaire-based mixed-methods study included adults transplanted between 1/4/13–31/3/17 at 14 UK hospitals. Participants were asked to indicate why relatives could not donate, selecting all options applicable from: Age; Health; Weight; Location; Financial/Cost; Job; Blood group; No-one to care for them after donation. A box entitled ‘Other—please give details’ was provided for free-text entries. Multivariable logistic regression was used to analyse the association between the likelihood of selecting each reason for non-donation and the participant’s self-reported ethnicity. Qualitative responses were analysed using inductive thematic analysis. In total, 1240 questionnaires were returned (40% response). There was strong evidence that Black, Asian and minority ethnic group individuals were more likely than White people to indicate that family members lived too far away to donate (adjusted odds ratio (aOR) = 3.25, 95% Confidence Interval (CI) 2.30–4.58), were prevented from donating by financial concerns (aOR = 2.95, 95% CI 2.02–4.29), were unable to take time off work (aOR = 1.88, 95% CI 1.18–3.02), were “not the right blood group” (aOR = 1.65, 95% CI 1.35–2.01), or had no-one to care for them post-donation (aOR = 3.73, 95% CI 2.60–5.35). Four qualitative themes were identified from responses from Black, Asian and minority ethnic group participants: ‘Burden of disease within the family’; ‘Differing religious interpretations’; ‘Geographical concerns’; and ‘A culture of silence’. Patients perceive barriers to living kidney donation in the UK Black, Asian and minority ethnic population. If confirmed, these could be targeted by interventions to redress the observed ethnic inequity.
- 21 November 2020
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 9 (11) , 3751
Open AccessInvestigating Ethnic Disparity in Living-Donor Kidney Transplantation in the UK: Patient-Identified Reasons for Non-Donation among Family Members
There is ethnic inequity in access to living-donor kidney transplants in the UK. This study asked kidney patients from Black, Asian and minority ethnic groups why members of their family were not able to be living kidney donors. Responses were compared with responses from White individuals. This questionnaire-based mixed-methods study included adults transplanted between 1/4/13–31/3/17 at 14 UK hospitals. Participants were asked to indicate why relatives could not donate, selecting all options applicable from: Age; Health; Weight; Location; Financial/Cost; Job; Blood group; No-one to care for them after donation. A box entitled ‘Other—please give details’ was provided for free-text entries. Multivariable logistic regression was used to analyse the association between the likelihood of selecting each reason for non-donation and the participant’s self-reported ethnicity. Qualitative responses were analysed using inductive thematic analysis. In total, 1240 questionnaires were returned (40% response). There was strong evidence that Black, Asian and minority ethnic group individuals were more likely than White people to indicate that family members lived too far away to donate (adjusted odds ratio (aOR) = 3.25, 95% Confidence Interval (CI) 2.30–4.58), were prevented from donating by financial concerns (aOR = 2.95, 95% CI 2.02–4.29), were unable to take time off work (aOR = 1.88, 95% CI 1.18–3.02), were “not the right blood group” (aOR = 1.65, 95% CI 1.35–2.01), or had no-one to care for them post-donation (aOR = 3.73, 95% CI 2.60–5.35). Four qualitative themes were identified from responses from Black, Asian and minority ethnic group participants: ‘Burden of disease within the family’; ‘Differing religious interpretations’; ‘Geographical concerns’; and ‘A culture of silence’. Patients perceive barriers to living kidney donation in the UK Black, Asian and minority ethnic population. If confirmed, these could be targeted by interventions to redress the observed ethnic inequity.
- 25 August 2020
- Published by Wolters Kluwer Health in Clinical Journal of the American Society of Nephrology
- Vol. 15 (9) , 1330-1339
Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation
Background and objectives: The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics. Design, setting, participants, & measurements: Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months. Results: A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m2 lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, −1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, −0.7 to 2.0) in controls. The between-group difference was −0.5 mm Hg (95% confidence interval, −2.8 to 1.7; P=0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, −0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, −0.2 to 0.3; P=0.49). Conclusions: Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls. Clinical Trial registry name and registration number: NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).
- 25 August 2020
- Published by Wolters Kluwer Health in Clinical Journal of the American Society of Nephrology
- Vol. 15 (9) , 1330-1339
Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation
Background and objectives: The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics. Design, setting, participants, & measurements: Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months. Results: A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m2 lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, −1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, −0.7 to 2.0) in controls. The between-group difference was −0.5 mm Hg (95% confidence interval, −2.8 to 1.7; P=0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, −0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, −0.2 to 0.3; P=0.49). Conclusions: Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls. Clinical Trial registry name and registration number: NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).
- 28 May 2020
- Published by Wolters Kluwer Health in Clinical Journal of the American Society of Nephrology
- Vol. 15 (6) , 830-842
Inequity in Access to Transplantation in the United Kingdom
Background and objectives: Despite the presence of a universal health care system, it is unclear if there is intercenter variation in access to kidney transplantation in the United Kingdom. This study aims to assess whether equity exists in access to kidney transplantation in the United Kingdom after adjustment for patient-specific factors and center practice patterns. Design, setting, participants, & measurements: In this prospective, observational cohort study including all 71 United Kingdom kidney centers, incident RRT patients recruited between November 2011 and March 2013 as part of the Access to Transplantation and Transplant Outcome Measures study were analyzed to assess preemptive listing (n=2676) and listing within 2 years of starting dialysis (n=1970) by center. Results: Seven hundred and six participants (26%) were listed preemptively, whereas 585 (30%) were listed within 2 years of commencing dialysis. The interquartile range across centers was 6%–33% for preemptive listing and 25%–40% for listing after starting dialysis. Patient factors, including increasing age, most comorbidities, body mass index >35 kg/m2, and lower socioeconomic status, were associated with a lower likelihood of being listed and accounted for 89% and 97% of measured intercenter variation for preemptive listing and listing within 2 years of starting dialysis, respectively. Asian (odds ratio, 0.49; 95% confidence interval, 0.33 to 0.72) and Black (odds ratio, 0.43; 95% confidence interval, 0.26 to 0.71) participants were both associated with reduced access to preemptive listing; however Asian participants were associated with a higher likelihood of being listed after starting dialysis (odds ratio, 1.42; 95% confidence interval, 1.12 to 1.79). As for center factors, being registered at a transplanting center (odds ratio, 3.1; 95% confidence interval, 2.36 to 4.07) and a universal approach to discussing transplantation (odds ratio, 1.4; 95% confidence interval, 1.08 to 1.78) were associated with higher preemptive listing, whereas using a written protocol was associated negatively with listing within 2 years of starting dialysis (odds ratio, 0.7; 95% confidence interval, 0.58 to 0.9). Conclusions: Patient case mix accounts for most of the intercenter variation seen in access to transplantation in the United Kingdom, with practice patterns also contributing some variation. Socioeconomic inequity exists despite having a universal health care system.
- 28 May 2020
- Published by Wolters Kluwer Health in Clinical Journal of the American Society of Nephrology
- Vol. 15 (6) , 830-842
Inequity in Access to Transplantation in the United Kingdom
Background and objectives: Despite the presence of a universal health care system, it is unclear if there is intercenter variation in access to kidney transplantation in the United Kingdom. This study aims to assess whether equity exists in access to kidney transplantation in the United Kingdom after adjustment for patient-specific factors and center practice patterns. Design, setting, participants, & measurements: In this prospective, observational cohort study including all 71 United Kingdom kidney centers, incident RRT patients recruited between November 2011 and March 2013 as part of the Access to Transplantation and Transplant Outcome Measures study were analyzed to assess preemptive listing (n=2676) and listing within 2 years of starting dialysis (n=1970) by center. Results: Seven hundred and six participants (26%) were listed preemptively, whereas 585 (30%) were listed within 2 years of commencing dialysis. The interquartile range across centers was 6%–33% for preemptive listing and 25%–40% for listing after starting dialysis. Patient factors, including increasing age, most comorbidities, body mass index >35 kg/m2, and lower socioeconomic status, were associated with a lower likelihood of being listed and accounted for 89% and 97% of measured intercenter variation for preemptive listing and listing within 2 years of starting dialysis, respectively. Asian (odds ratio, 0.49; 95% confidence interval, 0.33 to 0.72) and Black (odds ratio, 0.43; 95% confidence interval, 0.26 to 0.71) participants were both associated with reduced access to preemptive listing; however Asian participants were associated with a higher likelihood of being listed after starting dialysis (odds ratio, 1.42; 95% confidence interval, 1.12 to 1.79). As for center factors, being registered at a transplanting center (odds ratio, 3.1; 95% confidence interval, 2.36 to 4.07) and a universal approach to discussing transplantation (odds ratio, 1.4; 95% confidence interval, 1.08 to 1.78) were associated with higher preemptive listing, whereas using a written protocol was associated negatively with listing within 2 years of starting dialysis (odds ratio, 0.7; 95% confidence interval, 0.58 to 0.9). Conclusions: Patient case mix accounts for most of the intercenter variation seen in access to transplantation in the United Kingdom, with practice patterns also contributing some variation. Socioeconomic inequity exists despite having a universal health care system.
- 6 April 2020
- Published by Wolters Kluwer Health in Journal of the American Society of Nephrology
- Vol. 31 (5) , 1118-1127
Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial
Significance Statement: Experimental and observational data have raised concerns that intravenous (IV) iron might increase the risk of infections. In this analysis from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial involving 2141 patients on hemodialysis randomly assigned to receive either a high-dose or low-dose IV iron regimen, investigators reported finding no evidence that the two groups differed in incidence of infection, hospitalization for infection, or death from infection. Given the potential cardiovascular benefits of higher-dose IV iron seen in the PIVOTAL trial (due to either a direct effect of the IV iron or a decreased use of erythropoiesis-stimulating agents and thus, less exposure to associated cardiotoxic effects), this analysis provides reassurance for administering higher doses of IV iron than are currently given in many units worldwide. Background: Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis. Methods: Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter). Results: We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes. Conclusions: The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.
- 6 April 2020
- Published by Wolters Kluwer Health in Journal of the American Society of Nephrology
- Vol. 31 (5) , 1118-1127
Intravenous Iron Dosing and Infection Risk in Patients on Hemodialysis: A Prespecified Secondary Analysis of the PIVOTAL Trial
Significance Statement: Experimental and observational data have raised concerns that intravenous (IV) iron might increase the risk of infections. In this analysis from the Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial involving 2141 patients on hemodialysis randomly assigned to receive either a high-dose or low-dose IV iron regimen, investigators reported finding no evidence that the two groups differed in incidence of infection, hospitalization for infection, or death from infection. Given the potential cardiovascular benefits of higher-dose IV iron seen in the PIVOTAL trial (due to either a direct effect of the IV iron or a decreased use of erythropoiesis-stimulating agents and thus, less exposure to associated cardiotoxic effects), this analysis provides reassurance for administering higher doses of IV iron than are currently given in many units worldwide. Background: Experimental and observational studies have raised concerns that giving intravenous (IV) iron to patients, such as individuals receiving maintenance hemodialysis, might increase the risk of infections. The Proactive IV Iron Therapy in Haemodialysis Patients (PIVOTAL) trial randomized 2141 patients undergoing maintenance hemodialysis for ESKD to a high-dose or a low-dose IV iron regimen, with a primary composite outcome of all-cause death, heart attack, stroke, or hospitalization for heart failure. Comparison of infection rates between the two groups was a prespecified secondary analysis. Methods: Secondary end points included any infection, hospitalization for infection, and death from infection; we calculated cumulative event rates for these end points. We also interrogated the interaction between iron dose and vascular access (fistula versus catheter). Results: We found no significant difference between the high-dose IV iron group compared with the lose-dose group in event rates for all infections (46.5% versus 45.5%, respectively, which represented incidences of 63.3 versus 69.4 per 100 patient years, respectively); rates of hospitalization for infection (29.6% versus 29.3%, respectively) also did not differ. We did find a significant association between risk of a first cardiovascular event and any infection in the previous 30 days. Compared with patients undergoing dialysis with an arteriovenous fistula, those doing so via a catheter had a higher incidence of having any infection, hospitalization for infection, or fatal infection, but IV iron dosing had no effect on these outcomes. Conclusions: The high-dose and low-dose IV iron groups exhibited identical infection rates. Risk of a first cardiovascular event strongly associated with a recent infection.