Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI)

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.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: TIW dialysis strategy; Other: Conservative dialysis strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Medical Center Moffitt-Long Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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): Blood urea nitrogen >112 mg/dL (40 mmol/L); Serum potassium concentration >6 mmol/L; Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate); Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L; Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kathleen Liu, MD, PhD, University of California, San Francisco; Principal Investigator: Chi-yuan Hsu, MD, MSc, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dialysis-requiring Acute Kidney Injury; Renal Recovery
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: F32DK115030 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No