Recovery After Dialysis-Requiring Acute Kidney Injury

NCT ID: NCT03305549

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2019-11-13

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.

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TIW Dialysis Strategy

Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.

Group Type: ACTIVE_COMPARATOR

TIW dialysis strategy

Intervention Type: OTHER

Thrice-weekly acute intermittent hemodialysis schedule.

Conservative Dialysis Strategy

Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.

Group Type: EXPERIMENTAL

Conservative dialysis strategy

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

TIW dialysis strategy

Thrice-weekly acute intermittent hemodialysis schedule.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi-yuan Hsu, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kathleen Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Medical Center Moffitt-Long Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

F32DK115030

Identifier Type: NIH

Identifier Source: secondary_id

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F32DK115030

Identifier Type: NIH

Identifier Source: org_study_id

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