Heather Personett May

Background: Innovative care models are needed to address gaps in kidney care follow-up among acute kidney injury (AKI) survivors. We developed the multidisciplinary AKI in Care Transitions (ACT) program, which embeds post-AKI care in patients’ primary care clinic. Objective: The objective of this randomized pilot trial is to test the feasibility and acceptability of the ACT program and study protocol, including recruitment and retention, procedures, and outcome measures. Methods: The study will be conducted at Mayo Clinic in Rochester, Minnesota, a tertiary care center with a local primary care practice. Individuals who are included have stage 3 AKI during their hospitalization, do not require dialysis at discharge, have a local primary care provider, and are discharged to their home. Patients unable or unwilling to provide informed consent and recipients of any transplant within 100 days of enrollment are excluded. Consented patients are randomized to receive the intervention (ie, ACT program) or usual care. The ACT program intervention includes predischarge kidney health education from nurses and coordinated postdischarge laboratory monitoring (serum creatinine and urine protein assessment) and follow-up with a primary care provider and pharmacist within 14 days. The usual care group receives no specific study-related intervention, and any aspects of AKI care are at the direction of the treating team. This study will examine the feasibility of the ACT program, including recruitment, randomization and retention in a trial setting, and intervention fidelity. The feasibility and acceptability of participating in the ACT program will also be examined in qualitative interviews with patients and staff and through surveys. Qualitative interviews will be deductively and inductively coded and themes compared across data types. Observations of clinical encounters will be examined for discussion and care plans related to kidney health. Descriptive analyses will summarize quantitative measures of the feasibility and acceptability of ACT. Participants’ knowledge about kidney health, quality of life, and process outcomes (eg, type and timing of laboratory assessments) will be described for both groups. Clinical outcomes (eg, unplanned rehospitalization) up to 12 months will be compared with Cox proportional hazards models. Results: This study received funding from the Agency for Health Care Research and Quality on April 21, 2021, and was approved by the Institutional Review Board on December 14, 2021. As of March 14, 2023, seventeen participants each have been enrolled in the intervention and usual care groups. Conclusions: Feasible and generalizable AKI survivor care delivery models are needed to improve care processes and health outcomes. This pilot trial will test the ACT program, which uses a multidisciplinary model focused on primary care to address this gap. Trial Registration: ClinicalTrials.gov NCT05184894; https://www.clinicaltrials.gov/ct2/show/NCT05184894 International Registered Report Identifier (IRRID): DERR1-10.2196/48109

Solid organ transplant recipients are reliant on immunosuppressive drugs, which have a narrow therapeutic index, and are concurrently vulnerable to adverse drug events due to comorbidity burden and the complexity of their medication regimens. Urgent management of post‐transplant complications often falls to the generalist clinician or critical care specialist. The purpose of this narrative review is to discuss innovations and bedside applications of pharmacogenomics and therapeutic drug monitoring applied to immunosuppression and agents frequently encountered in transplant recipients. Medication formulations will be given specific attention, as interchange is frequently required in the acute care setting. Bioassays quantifying immune system activity will be described with practical applications. A structured approach to addressing drug–drug, drug‐gene, and drug–drug‐gene interactions will be modeled using a case‐based approach synthesizing pharmacogenomics, therapeutic drug monitoring, pharmacokinetics, and pharmacodynamic principles.

BACKGROUND Innovative care models are needed to address gaps in kidney care follow-up among acute kidney injury (AKI) survivors. We developed the multidisciplinary AKI in Care Transitions (ACT) program, which embeds post-AKI care in patients’ primary care clinic. OBJECTIVE The objective of this randomized pilot trial is to test the feasibility and acceptability of the ACT program and study protocol, including recruitment and retention, procedures, and outcome measures. METHODS The study will be conducted at Mayo Clinic in Rochester, Minnesota, a tertiary care center with a local primary care practice. Individuals who are included have stage 3 AKI during their hospitalization, do not require dialysis at discharge, have a local primary care provider, and are discharged to their home. Patients unable or unwilling to provide informed consent and recipients of any transplant within 100 days of enrollment are excluded. Consented patients are randomized to receive the intervention (ie, ACT program) or usual care. The ACT program intervention includes predischarge kidney health education from nurses and coordinated postdischarge laboratory monitoring (serum creatinine and urine protein assessment) and follow-up with a primary care provider and pharmacist within 14 days. The usual care group receives no specific study-related intervention, and any aspects of AKI care are at the direction of the treating team. This study will examine the feasibility of the ACT program, including recruitment, randomization and retention in a trial setting, and intervention fidelity. The feasibility and acceptability of participating in the ACT program will also be examined in qualitative interviews with patients and staff and through surveys. Qualitative interviews will be deductively and inductively coded and themes compared across data types. Observations of clinical encounters will be examined for discussion and care plans related to kidney health. Descriptive analyses will summarize quantitative measures of the feasibility and acceptability of ACT. Participants’ knowledge about kidney health, quality of life, and process outcomes (eg, type and timing of laboratory assessments) will be described for both groups. Clinical outcomes (eg, unplanned rehospitalization) up to 12 months will be compared with Cox proportional hazards models. RESULTS This study received funding from the Agency for Health Care Research and Quality on April 21, 2021, and was approved by the Institutional Review Board on December 14, 2021. As of March 14, 2023, seventeen participants each have been enrolled in the intervention and usual care groups. CONCLUSIONS Feasible and generalizable AKI survivor care delivery models are needed to improve care processes and health outcomes. This pilot trial will test the ACT program, which uses a multidisciplinary model focused on primary care to address this gap. CLINICALTRIAL ClinicalTrials.gov NCT05184894; https://www.clinicaltrials.gov/ct2/show/NCT05184894 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/48109

PURPOSE: High-dose methotrexate (HDMTX; > 500 mg/m²) is an important component of lymphoma therapy. Serum MTX monitoring at 48 hours is the standard approach to identify those at increased risk of developing MTX toxicity. Our aim was to characterize the incidence of complications and their association with MTX levels.METHODS: A retrospective review of our institutional electronic medical record was conducted to identify patients with lymphoma who received HDMTX between January 1, 2002, and December 31, 2018. We characterized the incidence of acute kidney injury (AKI), intensive care unit (ICU) admission, length of hospital stay (LOS), and 30-day mortality across 48-hour MTX levels. To establish an association between 48-hour MTX levels and the complications listed, we performed chi-square analysis for dichotomous variables and Kruskal-Wallis for nonparametric data. Receiver operator characteristic curve analysis was performed to identify the MTX level where AKI grade ≥ 2 was more likely. Multivariate logistic regression analysis was performed to identify risk factors for this MTX level.RESULTS: We identified 642 patients with 2,804 cycles of HDMTX. The incidence of AKI was 19.1% with AKI grade ≥ 2 making up 21% of cases. Rates of AKI, ICU admission, and 30-day mortality are associated with elevated 48-hour MTX levels. There was a significant increase in median LOS with elevated MTX levels ( P < .001). Receiver operator characteristic curve analysis for AKI grade ≥ 2 demonstrated a 48-hour MTX level threshold of 1.28 μmol/L. Multivariate logistic regression analysis revealed age, male sex, elevated body surface area, higher MTX dose, monotherapy, and first cycle as independent factors.CONCLUSION: Elevated MTX levels are associated with a significant increased rate of AKI, ICU admission, prolonged LOS, and 30-day mortality. Elevated 48-hour MTX levels, particularly > 1.28 μmol/L, should alert clinicians for complications and to initiate measures to reduce MTX levels.

Introduction: Acute kidney injury (AKI) affects nearly 20% of all hospitalised patients and is associated with poor outcomes. Long-term complications can be partially attributed to gaps in kidney-focused care and education during transitions. Building capacity across the healthcare spectrum by engaging a broad network of multidisciplinary providers to facilitate optimal follow-up care represents an important mechanism to address this existing care gap. Key participants include nephrologists and primary care providers and in-depth study of each specialty’s approach to post-AKI care is essential to optimise care processes and healthcare delivery for AKI survivors. Methods and analysis: This explanatory sequential mixed-methods study uses survey and interview methodology to assess nephrologist and primary care provider recommendations for post-AKI care, including KAMPS (kidney function assessment, awareness and education, medication review, blood pressure monitoring and sick day education) elements of follow-up, the role of multispecialty collaboration, and views on care process-specific and patient-specific factors influencing healthcare delivery. Nephrologists and primary care providers will be surveyed to assess recommendations and clinical decision-making in the context of post-AKI care. Descriptive statistics and the Pearson’s χ ² or Fisher’s exact test will be used to compare results between groups. This will be followed by semistructured interviews to gather rich, qualitative data that explains and/or connects results from the quantitative survey. Both deductive analysis and inductive analysis will occur to identify and compare themes. Ethics and dissemination: This study has been reviewed and deemed exempt by the Institutional Review Board at Mayo Clinic (IRB 20–0 08 793). The study was deemed exempt due to the sole use of survey and interview methodology. Results will be disseminated in presentations and manuscript form through peer-reviewed publication.

Uric acid drives acute kidney injury in tumor lysis syndrome (TLS). This study investigated the relationship between uric acid and changes in estimated glomerular filtration rate (eGFR) in adults at risk for TLS. Linear regression was used to evaluate the relationship between uric acid area under the curve (AUC) and percent change in eGFR from baseline at hospital dismissal, 1 and 3 months. In 210 included participants, each 100 mg*hour/dL increase in 24 h AUC was associated with an average decline in eGFR at hospital dismissal of 9% (95%CI 3, 15) in univariate analysis. Each 100 mg*hour/dL increase in 24 h AUC was independently associated with an average decline in eGFR of 8% (95%CI 2, 13) at 1 month after dismissal. Additional research is needed to confirm these findings and determine whether treatments that reduce overall uric acid exposure improve kidney outcomes. Preserving kidney health could favorably impact cancer treatment eligibility, tolerability, and outcomes.