Clinical trial NCT03305549: Recovery After Dialysis-Requiring Acute Kidney Injury
Official title: Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Dialysis-requiring Acute Kidney Injury
Renal Recovery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol adherence [feasibility measure]
timeFrame: Through completion of active study participation (anticipated <2 weeks for each participant)
measure: Number of participants with adverse events in each arm [safety measure]
timeFrame: Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary outcomes:
measure: Patient-reported symptoms
timeFrame: Through completion of active study participation (anticipated <2 weeks for each participant)
measure: Hospital length of stay
timeFrame: Through completion of active study participation (anticipated <2 weeks for each participant)
measure: Recovery status at 30, 60, and 90 days after dialysis initiation
timeFrame: From enrollment to 90 days after dialysis initiation for each patient
measure: Screen-to-enroll ratio [feasibility measure]
timeFrame: Through study completion (anticipated 2 years total)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center Moffitt-Long Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Chi-yuan Hsu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kathleen Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: