Daniel Michael Fatovich
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
Research Interests
Daniel Michael Fatovich has a total of 582 co-authors. Here are the top co-authors by number of shared publications:
- Glenn Arendts
Medical School The University of Western Australia Perth Western Australia Australia
31 shared publications - Stephen Pj Macdonald
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Australia
27 shared publications - Judith Finn
Prehospital, Resuscitation and Emergency Care Research Unit (PRECRU), Curtin School of Nursing, Curtin University, Bentley, Western Australia, Australia
18 shared publications Antonio Celenza
Medical School, University of Western Australia, Crawley, WA, Australia; Sir Charles Gairdner Hospital, Nedlands, WA, Australia
13 shared publications- Diana Egerton‐Warburton
Emergency Department, Monash Health, Clayton, Victoria, Australia
13 shared publications Paul Bailey
Prehospital, Resuscitation and Emergency Care Research Unit (PRECRU), Curtin University, Bentley, WA, Australia; St John Western Australia, Belmont, WA, Australia
13 shared publications
Latest Publications
- Open Access
- 25 August 2026
- Published by Springer Nature in Journal of Neurology
- Vol. 273 (9) , 548
Divergent recovery trajectories after mild traumatic brain injury are characterized by distinct acute profiles of neurofilament light, 4R-tau, and white matter diffusivity
Objectives: Blood-based and diffusion MRI (dMRI) biomarkers of white matter injury after acute mild traumatic brain injury (mTBI) were examined to: (1) distinguish mTBI from healthy controls (HC); (2) quantify inter-modality relationships; (3) identify associations between acute biomarker changes and recovery; (4) evaluate moderating influences of resilience and coping style. Methods: 36 adults with mTBI (37.6±13.7 years; 37.1% female) and 35 HC participants (34.2 ± 11.9; 47.1% female) underwent baseline testing (≤ 9 days post-mTBI) including: blood-sampling (neurofilament light-chain [NfL], brain-derived tau, glial fibrillary acidic protein, ubiquitin carboxyl terminal hydroxylase-L1, four-repeat tau [4R-tau]), dMRI analysis of 48 white matter tracts, symptom (Post-Concussion Symptom Scale [PCSS]) and psychological questionnaires (Brief Resilience Scale, Utrecht Coping List). Recovery was determined at 3-, 6- and 12-month follow-ups using PCSS scores. Associations were evaluated using correlations, logistic regression, and exploratory moderation analyses. Trial registration Number: ACTRN12619001226190. Results: 37.1% of participants reported persistent symptoms at 3 months, 42.9% and 28.6% at 6 and 12 months, respectively. NfL and 4R-tau were acutely elevated post-mTBI, alongside widespread increases in radial, mean, and axial diffusivity. Divergent recovery trajectories were defined by distinct baseline biomarker profiles: elevated NfL and mean diffusivity characterized recovered participants, while elevated 4R-tau and radial diffusivity characterized those who remained symptomatic. NfL was associated with recovery at 3 months and 4R-tau with symptomatic status at 12 months. Coping style, not resilience, moderated blood biomarker–outcome relationships. Conclusion: Divergent acute profiles of blood biomarkers, white matter diffusivity, and coping style distinguish mTBI recovery trajectories, providing hypothesis-generating support for biologically informed molecular, microstructural, and psychological mTBI phenotypes. Trial registration number: ACTRN12619001226190 approved March 2023.
- 25 August 2026
- Published by Springer Nature in Journal of Neurology
- Vol. 273 (9) , 548
Open AccessDivergent recovery trajectories after mild traumatic brain injury are characterized by distinct acute profiles of neurofilament light, 4R-tau, and white matter diffusivity
Objectives: Blood-based and diffusion MRI (dMRI) biomarkers of white matter injury after acute mild traumatic brain injury (mTBI) were examined to: (1) distinguish mTBI from healthy controls (HC); (2) quantify inter-modality relationships; (3) identify associations between acute biomarker changes and recovery; (4) evaluate moderating influences of resilience and coping style. Methods: 36 adults with mTBI (37.6±13.7 years; 37.1% female) and 35 HC participants (34.2 ± 11.9; 47.1% female) underwent baseline testing (≤ 9 days post-mTBI) including: blood-sampling (neurofilament light-chain [NfL], brain-derived tau, glial fibrillary acidic protein, ubiquitin carboxyl terminal hydroxylase-L1, four-repeat tau [4R-tau]), dMRI analysis of 48 white matter tracts, symptom (Post-Concussion Symptom Scale [PCSS]) and psychological questionnaires (Brief Resilience Scale, Utrecht Coping List). Recovery was determined at 3-, 6- and 12-month follow-ups using PCSS scores. Associations were evaluated using correlations, logistic regression, and exploratory moderation analyses. Trial registration Number: ACTRN12619001226190. Results: 37.1% of participants reported persistent symptoms at 3 months, 42.9% and 28.6% at 6 and 12 months, respectively. NfL and 4R-tau were acutely elevated post-mTBI, alongside widespread increases in radial, mean, and axial diffusivity. Divergent recovery trajectories were defined by distinct baseline biomarker profiles: elevated NfL and mean diffusivity characterized recovered participants, while elevated 4R-tau and radial diffusivity characterized those who remained symptomatic. NfL was associated with recovery at 3 months and 4R-tau with symptomatic status at 12 months. Coping style, not resilience, moderated blood biomarker–outcome relationships. Conclusion: Divergent acute profiles of blood biomarkers, white matter diffusivity, and coping style distinguish mTBI recovery trajectories, providing hypothesis-generating support for biologically informed molecular, microstructural, and psychological mTBI phenotypes. Trial registration number: ACTRN12619001226190 approved March 2023.
- 12 August 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (4)
Artificial Intelligence and Academic Publishing
- 12 August 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (4)
Artificial Intelligence and Academic Publishing
- Open Access
- 27 July 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (4) , e70314
One‐Year Reattendance Rates to the Emergency Department for Acute Illicit Drug Exposure in Western Australia: A Retrospective Registry Study
Objective: Determine 1‐year emergency department (ED) drug‐related reattendance rates of patients enrolled in the Emerging Drugs Network of Australia across five Western Australian hospitals. Methods: Index presentations and 1‐year reattendances were extracted. Reattendance rates were calculated and stratified by confirmed novel or traditional illicit drugs. Results: Of 1141 patients, 5.0% (95% CI: 3.9%–6.4%) reattended the ED for drug exposure within 1 year. No statistical differences between novel and traditional illicit drugs were identified. Conclusion: A conservative but discernible reattendance rate with confirmed illicit drug exposure was demonstrated. Objective data can inform hospital‐based harm reduction services and reduce future drug exposure risk.
- 27 July 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (4) , e70314
Open AccessOne‐Year Reattendance Rates to the Emergency Department for Acute Illicit Drug Exposure in Western Australia: A Retrospective Registry Study
Objective: Determine 1‐year emergency department (ED) drug‐related reattendance rates of patients enrolled in the Emerging Drugs Network of Australia across five Western Australian hospitals. Methods: Index presentations and 1‐year reattendances were extracted. Reattendance rates were calculated and stratified by confirmed novel or traditional illicit drugs. Results: Of 1141 patients, 5.0% (95% CI: 3.9%–6.4%) reattended the ED for drug exposure within 1 year. No statistical differences between novel and traditional illicit drugs were identified. Conclusion: A conservative but discernible reattendance rate with confirmed illicit drug exposure was demonstrated. Objective data can inform hospital‐based harm reduction services and reduce future drug exposure risk.
- Open Access
- 15 June 2026
- Published by Wiley in Drug and Alcohol Review
- Vol. 45 (5) , e70193
Accuracy of Patient‐Reported Exposure to New Psychoactive Substances and Other Illicit Drugs in Australian Emergency Departments: Findings From the Emerging Drugs Network of Australia
Introduction: New psychoactive substances (NPS) present a unique challenge in clinical, public health and drug‐policy contexts. Continued diversity, unknown potency and often unintentional exposure can limit the accuracy of self‐reported data. This study examined the accuracy of patient‐reported NPS and illicit drug exposure in Australian emergency departments (ED). Methods: Patient‐reported drug exposure, clinical and toxicology data were extracted from the Emerging Drugs Network of Australia Clinical Registry between 1 July 2021 and 30 June 2024 for patients presenting with severe and/or unusual illicit drug toxicity in the ED. Blood samples were analysed using mass spectrometry. Agreement between reported and confirmed exposure was assessed using Cohen's kappa, sensitivity, specificity and likelihood ratios. Logistic regression analysis identified factors associated with discrepancies between reported and confirmed exposures. Results: There were 2044 presentations: 64.6% male, median age 33 years (Q1–Q3, 26–41). Complete agreement between patient‐reported and confirmed drug exposures was 14.3% ( n = 293). Agreement between reported and confirmed NPS exposure was poor ( κ = 0.38). 1522 (74.5%) had more drugs detected than reported. Older age (OR 1.03 [CI 1.02, 1.04]) was associated with higher odds of discrepancy. Attendance from a licensed venue (OR 0.44 [CI 0.28, 0.70]) and Glasgow Coma Scale of 13–15 (OR 0.44 [CI 0.33, 0.57]) were associated with lower odds. Discussion and Conclusions: Poor agreement between patient‐reported and analytically confirmed drug exposure highlights the need for continued partnerships between EDs, clinical toxicologists, and forensic laboratories to identify substances involved in acute intoxications and support public health and harm reduction responses.
- 15 June 2026
- Published by Wiley in Drug and Alcohol Review
- Vol. 45 (5) , e70193
Open AccessAccuracy of Patient‐Reported Exposure to New Psychoactive Substances and Other Illicit Drugs in Australian Emergency Departments: Findings From the Emerging Drugs Network of Australia
Introduction: New psychoactive substances (NPS) present a unique challenge in clinical, public health and drug‐policy contexts. Continued diversity, unknown potency and often unintentional exposure can limit the accuracy of self‐reported data. This study examined the accuracy of patient‐reported NPS and illicit drug exposure in Australian emergency departments (ED). Methods: Patient‐reported drug exposure, clinical and toxicology data were extracted from the Emerging Drugs Network of Australia Clinical Registry between 1 July 2021 and 30 June 2024 for patients presenting with severe and/or unusual illicit drug toxicity in the ED. Blood samples were analysed using mass spectrometry. Agreement between reported and confirmed exposure was assessed using Cohen's kappa, sensitivity, specificity and likelihood ratios. Logistic regression analysis identified factors associated with discrepancies between reported and confirmed exposures. Results: There were 2044 presentations: 64.6% male, median age 33 years (Q1–Q3, 26–41). Complete agreement between patient‐reported and confirmed drug exposures was 14.3% ( n = 293). Agreement between reported and confirmed NPS exposure was poor ( κ = 0.38). 1522 (74.5%) had more drugs detected than reported. Older age (OR 1.03 [CI 1.02, 1.04]) was associated with higher odds of discrepancy. Attendance from a licensed venue (OR 0.44 [CI 0.28, 0.70]) and Glasgow Coma Scale of 13–15 (OR 0.44 [CI 0.33, 0.57]) were associated with lower odds. Discussion and Conclusions: Poor agreement between patient‐reported and analytically confirmed drug exposure highlights the need for continued partnerships between EDs, clinical toxicologists, and forensic laboratories to identify substances involved in acute intoxications and support public health and harm reduction responses.
- Open Access
- 7 June 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (3) , e70284
Analytically Confirmed Opioid Detections From the Emerging Drugs Network of Australia
Objective: We describe analytically confirmed opioid‐related presentations to emergency departments (EDs) in Australia. Methods: Presentations with analytically confirmed opioid exposure, between January 2021 and December 2024, were identified from the Emerging Drugs Network of Australia (EDNA) Clinical Registry. Demographic data, clinical features, outcomes, naloxone dosing, and analytical toxicology results were extracted. Results: Opioids were detected in 793 ED presentations. The majority were male (568, 71.6%) with a median age of 40 years (Q1–Q3: 30–48 years). Patients were unwell (Australasian Triage Score 1 or 2 = 700, 88.3%). Suicidal intent was noted in 55 (6.9%) presentations. Mono‐opioid detections occurred in 550 (69.4%) presentations, most frequently heroin exposures (162, 29.5%). Novel opioids including nitazenes and U‐Class synthetic opioids were uncommon (21, 2.6%). Illicit co‐detections were common (547, 69.0%) especially with methylamphetamine (512, 64.6%), gamma‐hydroxybutyrate (108, 13.6%), and diazepam (341, 43%). Naloxone was used in 498 (62.8%) presentations: median dose 400 μg (IQR: 200–600 μg). There was no difference in median naloxone dose for heroin (median 320 μg) and novel opioids (median 500 μg, p = 0.25). Intubation was more likely to occur in patients with novel opioids compared to heroin (8/21, 26/162, p = 0.020). Conclusions: Heroin was the most common analytically confirmed illicit opioid detected among opioid‐related ED presentations. Novel opioids were uncommon with no difference in median naloxone dose used. There were higher intubation rates for novel opioids. Polydrug exposure is common, complicating the clinical picture. Increased awareness of the national Take Home Naloxone program, particularly by emergency physicians, is a key element of harm reduction.
- 7 June 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (3) , e70284
Open AccessAnalytically Confirmed Opioid Detections From the Emerging Drugs Network of Australia
Objective: We describe analytically confirmed opioid‐related presentations to emergency departments (EDs) in Australia. Methods: Presentations with analytically confirmed opioid exposure, between January 2021 and December 2024, were identified from the Emerging Drugs Network of Australia (EDNA) Clinical Registry. Demographic data, clinical features, outcomes, naloxone dosing, and analytical toxicology results were extracted. Results: Opioids were detected in 793 ED presentations. The majority were male (568, 71.6%) with a median age of 40 years (Q1–Q3: 30–48 years). Patients were unwell (Australasian Triage Score 1 or 2 = 700, 88.3%). Suicidal intent was noted in 55 (6.9%) presentations. Mono‐opioid detections occurred in 550 (69.4%) presentations, most frequently heroin exposures (162, 29.5%). Novel opioids including nitazenes and U‐Class synthetic opioids were uncommon (21, 2.6%). Illicit co‐detections were common (547, 69.0%) especially with methylamphetamine (512, 64.6%), gamma‐hydroxybutyrate (108, 13.6%), and diazepam (341, 43%). Naloxone was used in 498 (62.8%) presentations: median dose 400 μg (IQR: 200–600 μg). There was no difference in median naloxone dose for heroin (median 320 μg) and novel opioids (median 500 μg, p = 0.25). Intubation was more likely to occur in patients with novel opioids compared to heroin (8/21, 26/162, p = 0.020). Conclusions: Heroin was the most common analytically confirmed illicit opioid detected among opioid‐related ED presentations. Novel opioids were uncommon with no difference in median naloxone dose used. There were higher intubation rates for novel opioids. Polydrug exposure is common, complicating the clinical picture. Increased awareness of the national Take Home Naloxone program, particularly by emergency physicians, is a key element of harm reduction.
- Open Access
- 28 May 2026
- Published by SAGE Publications in Health Information Management Journal
The positive predictive value of ICD-10-AM S06.0~ concussion codes for mild traumatic brain injury
Background: Increasing concern regarding long-term consequences of mild traumatic brain injury (mTBI; concussion) highlights the need for an accurate understanding of its epidemiological landscape. Current estimates of mTBI presentations to the emergency department (ED) are based on principal diagnosis International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) S06.0~ concussive injury codes assigned by the treating ED clinician in the ED information system (EDIS). While mTBI is defined by absence of loss of consciousness (LOC) or LOC < 30 minutes, the S06.0~ codes include injuries associated with longer periods of LOC. To ensure reliable case estimates to inform healthcare resource allocation, it is essential to understand which S06.0~ codes most accurately capture mTBI and to minimise its misclassification. Objective: To identify the positive predictive value (PPV) of principal diagnosis S06.0~ codes for mTBI using information from EDIS and retrospective chart review. Method: All episodes of care assigned principal diagnosis S06.0~ codes between 1 July 2022 and 30 June 2023 at Royal Perth Hospital ED, Western Australia, were identified, and clinical diagnoses were confirmed via medical record review. PPVs were calculated for each S06.0~ code, and logistic regression models implemented (RStudio v4.3.3) to explore the influence of patient characteristics on coding. Results: Code S06.00 was most frequently assigned ( n = 279, 51.7%). No cases were coded S06.04 or S06.05 (>24 hours LOC). For mTBI, the adjusted PPV of S06.0~ was 71.8% (95% confidence interval (CI) 66.85–76.22), increasing to 74.0% (95% CI 68.72–78.69) after excluding S06.03 (LOC 30 minutes to 24 hours). The highest PPV was observed for the four-digit S06.0 code (adjusted PPV = 87.0%; 95% CI 74.36–93.90). PPVs were lower among patients arriving via emergency transport, older adults (>65 years), and cases without a documented injury mechanism. Conclusion: There are limitations to using ICD-10-AM concussive injury codes to identify mTBI in ED settings, and patient characteristics influence coding accuracy. Reconsideration of current ED coding practices, including exploration of alternative models that reduce clinician burden and improve coding accuracy, is recommended. Implications for health information management practice: The introduction of electronic medical records provides an opportunity to standardise documentation of key clinical findings and develop artificial intelligence tools to improve coding of mTBI.
- 28 May 2026
- Published by SAGE Publications in Health Information Management Journal
Open AccessThe positive predictive value of ICD-10-AM S06.0~ concussion codes for mild traumatic brain injury
Background: Increasing concern regarding long-term consequences of mild traumatic brain injury (mTBI; concussion) highlights the need for an accurate understanding of its epidemiological landscape. Current estimates of mTBI presentations to the emergency department (ED) are based on principal diagnosis International Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) S06.0~ concussive injury codes assigned by the treating ED clinician in the ED information system (EDIS). While mTBI is defined by absence of loss of consciousness (LOC) or LOC < 30 minutes, the S06.0~ codes include injuries associated with longer periods of LOC. To ensure reliable case estimates to inform healthcare resource allocation, it is essential to understand which S06.0~ codes most accurately capture mTBI and to minimise its misclassification. Objective: To identify the positive predictive value (PPV) of principal diagnosis S06.0~ codes for mTBI using information from EDIS and retrospective chart review. Method: All episodes of care assigned principal diagnosis S06.0~ codes between 1 July 2022 and 30 June 2023 at Royal Perth Hospital ED, Western Australia, were identified, and clinical diagnoses were confirmed via medical record review. PPVs were calculated for each S06.0~ code, and logistic regression models implemented (RStudio v4.3.3) to explore the influence of patient characteristics on coding. Results: Code S06.00 was most frequently assigned ( n = 279, 51.7%). No cases were coded S06.04 or S06.05 (>24 hours LOC). For mTBI, the adjusted PPV of S06.0~ was 71.8% (95% confidence interval (CI) 66.85–76.22), increasing to 74.0% (95% CI 68.72–78.69) after excluding S06.03 (LOC 30 minutes to 24 hours). The highest PPV was observed for the four-digit S06.0 code (adjusted PPV = 87.0%; 95% CI 74.36–93.90). PPVs were lower among patients arriving via emergency transport, older adults (>65 years), and cases without a documented injury mechanism. Conclusion: There are limitations to using ICD-10-AM concussive injury codes to identify mTBI in ED settings, and patient characteristics influence coding accuracy. Reconsideration of current ED coding practices, including exploration of alternative models that reduce clinician burden and improve coding accuracy, is recommended. Implications for health information management practice: The introduction of electronic medical records provides an opportunity to standardise documentation of key clinical findings and develop artificial intelligence tools to improve coding of mTBI.
- 17 March 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (2) , e70243
The Potential for Artificial Intelligence to Augment Peer Review
- 17 March 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (2) , e70243
The Potential for Artificial Intelligence to Augment Peer Review
- 23 February 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (1) , e70232
The Current State of Peer Review
Peer review is a cornerstone of modern scientific publishing, yet its current form is a relatively recent development that became institutionalised in the mid‐20th century. While intended to ensure rigour, credibility and quality control, the peer review system now faces mounting pressures. Rapid growth in manuscript submissions, reliance on unpaid reviewer labour, reviewer fatigue and the rise of predatory journals have strained its effectiveness. These challenges contribute to delays, inconsistent review quality and increasing retraction rates, highlighting vulnerabilities that peer review often fails to detect at scale. Evidence from randomised trials suggests that most proposed reforms offer limited benefit, although adding statistical reviewers and adopting elements of open peer review produce modest improvements. Sustainable reform will require evidence‐guided changes, better recognition of reviewer contributions, and careful integration of technological tools to preserve the integrity of scientific publishing.
- 23 February 2026
- Published by Wiley in Emergency Medicine Australasia
- Vol. 38 (1) , e70232
The Current State of Peer Review
Peer review is a cornerstone of modern scientific publishing, yet its current form is a relatively recent development that became institutionalised in the mid‐20th century. While intended to ensure rigour, credibility and quality control, the peer review system now faces mounting pressures. Rapid growth in manuscript submissions, reliance on unpaid reviewer labour, reviewer fatigue and the rise of predatory journals have strained its effectiveness. These challenges contribute to delays, inconsistent review quality and increasing retraction rates, highlighting vulnerabilities that peer review often fails to detect at scale. Evidence from randomised trials suggests that most proposed reforms offer limited benefit, although adding statistical reviewers and adopting elements of open peer review produce modest improvements. Sustainable reform will require evidence‐guided changes, better recognition of reviewer contributions, and careful integration of technological tools to preserve the integrity of scientific publishing.
- Open Access
- 22 August 2025
- Published by Elsevier in International Journal of Drug Policy
- Vol. 145, 104969
Novel psychoactive substances in Australian emergency departments: implications for public health practice from multi-centre prospective toxicosurveillance across five states, 2022–2023
- 22 August 2025
- Published by Elsevier in International Journal of Drug Policy
- Vol. 145, 104969
Open AccessNovel psychoactive substances in Australian emergency departments: implications for public health practice from multi-centre prospective toxicosurveillance across five states, 2022–2023
- Open Access
Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol
Introduction International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain. Methods and analysis Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation. Ethics and dissemination The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences. Trial registration number NCT04569942
Open AccessAustralasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol
Introduction International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain. Methods and analysis Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation. Ethics and dissemination The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences. Trial registration number NCT04569942