Recovery After Dialysis-Requiring Acute Kidney Injury

NCT03305549 | Terminated DMC

• 1 other identifier: F32DK115030
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Dialysis-requiring Acute Kidney Injury; Renal Recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Patient-reported symptoms

  Through completion of active study participation (anticipated <2 weeks for each participant)

• Hospital length of stay

  Through completion of active study participation (anticipated <2 weeks for each participant)

• Recovery status at 30, 60, and 90 days after dialysis initiation

  From enrollment to 90 days after dialysis initiation for each patient

• Screen-to-enroll ratio [feasibility measure]

  Through study completion (anticipated 2 years total)

Study Arms (2)

TIW Dialysis Strategy

ACTIVE COMPARATOR

Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.

Other: TIW dialysis strategy

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.

Other: Conservative dialysis strategy

Interventions

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): * 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

Conservative Dialysis Strategy

TIW dialysis strategy OTHER

Thrice-weekly acute intermittent hemodialysis schedule.

TIW Dialysis Strategy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSF Medical Center Moffitt-Long Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chi-yuan Hsu, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kathleen Liu, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 10, 2017
• Study Start: September 29, 2017
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)