Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03305549|
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Other: Conservative dialysis strategy Other: TIW dialysis strategy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."|
|Masking:||None (Open Label)|
|Official Title:||Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study|
|Actual Study Start Date :||September 29, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Active Comparator: TIW Dialysis Strategy
Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
Other: TIW dialysis strategy
Thrice-weekly acute intermittent hemodialysis schedule.
Experimental: Conservative Dialysis Strategy
Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.
Other: Conservative dialysis strategy
Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):
- Protocol adherence [feasibility measure] [ Time Frame: 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] [ Time Frame: 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
- Patient-reported symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From enrollment to 90 days after dialysis initiation for each patient ]Assessment of recovery status via phone call or e-mail contact
- Screen-to-enroll ratio [feasibility measure] [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305549
|United States, California|
|UCSF Medical Center Moffitt-Long Hospital|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Chi-yuan Hsu, MD, MSc||University of California, San Francisco|
|Principal Investigator:||Kathleen Liu, MD, PhD||University of California, San Francisco|