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Recovery After Dialysis-Requiring Acute Kidney Injury

NCT03305549 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-19

No results posted yet for this study

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

Interventions

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

OTHER

TIW dialysis strategy

Thrice-weekly acute intermittent hemodialysis schedule.

Sponsors & Collaborators

Principal Investigators

  • Chi-yuan Hsu, MD, MSc · University of California, San Francisco

  • Kathleen Liu, MD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305549 on ClinicalTrials.gov