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| ID | Type | Description | Link |
|---|---|---|---|
| F32DK115030 | U.S. NIH Grant/Contract | View source |
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Study stopped because sufficient pilot data collected to proceed to next clinical trial.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIW Dialysis Strategy | Active Comparator | Conventional thrice-weekly acute intermittent hemodialysis treatment schedule. |
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| Conservative Dialysis Strategy | Experimental | Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative dialysis strategy | Other | Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):
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| Measure | Description | Time Frame |
|---|---|---|
| Protocol adherence [feasibility measure] | 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 | Through completion of active study participation (anticipated <2 weeks for each participant) |
| Number of participants with adverse events in each arm [safety measure] | 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 | Through completion of active study participation (anticipated <2 weeks for each participant) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported symptoms | Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema | Through completion of active study participation (anticipated <2 weeks for each participant) |
| Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi-yuan Hsu, MD, MSc | University of California, San Francisco | Principal Investigator |
| Kathleen Liu, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center Moffitt-Long Hospital | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
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| TIW dialysis strategy | Other | Thrice-weekly acute intermittent hemodialysis schedule. |
|
Length of inpatient admission, starting after study enrollment |
| Through completion of active study participation (anticipated <2 weeks for each participant) |
| Recovery status at 30, 60, and 90 days after dialysis initiation | Assessment of recovery status via phone call or e-mail contact | From enrollment to 90 days after dialysis initiation for each patient |
| Screen-to-enroll ratio [feasibility measure] | Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study | Through study completion (anticipated 2 years total) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |