Recovery After Dialysis-Requiring Acute Kidney Injury
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/17/2019 |
| Start Date: | September 29, 2017 |
| End Date: | January 1, 2020 |
Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
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.
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.
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.
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.
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
We found this trial at
1
site
505 Parnassus Avenue
San Francisco, California 94143
San Francisco, California 94143
Phone: 415-476-2172
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