Recovery After Dialysis-Requiring Acute Kidney Injury

Not Applicable

Terminated

Interventions: Other: TIW dialysis strategy
Other: Conservative dialysis strategy

Brief Summary: The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.

Detailed Description: The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery.

The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.

Recruitment & Eligibility

Inclusion Criteria

Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
Not requiring vasopressor support
Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment

Exclusion Criteria

Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
Liver transplant unit patients
Patients who underwent kidney transplantation during index hospitalization
Cause of AKI-D is complete nephrectomy
Current pregnancy

Arm && Interventions

Group	Intervention	Description
TIW Dialysis Strategy	TIW dialysis strategy	Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
Conservative Dialysis Strategy	Conservative dialysis strategy	Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.

Primary Outcome Measures

Name	Time	Method
Protocol adherence [feasibility measure]	Through completion of active study participation (anticipated <2 weeks for each participant)	Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Number of participants with adverse events in each arm [safety measure]	Through completion of active study participation (anticipated <2 weeks for each participant)	Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment

Secondary Outcome Measures

Name	Time	Method
Screen-to-enroll ratio [feasibility measure]	Through study completion (anticipated 2 years total)	Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
Patient-reported symptoms	Through completion of active study participation (anticipated <2 weeks for each participant)	Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
Hospital length of stay	Through completion of active study participation (anticipated <2 weeks for each participant)	Length of inpatient admission, starting after study enrollment
Recovery status at 30, 60, and 90 days after dialysis initiation	From enrollment to 90 days after dialysis initiation for each patient	Assessment of recovery status via phone call or e-mail contact

Locations (1): UCSF Medical Center Moffitt-Long Hospital
🇺🇸
San Francisco, California, United States