Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

NCT05158153 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 21-33602
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.

Conditions

Acute Kidney Injury; Dialysis Hypotension

Keywords

Dialysis-requiring Acute Kidney Injury; Renal Recovery

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.

  Feasibility

  First two weeks of study intervention

Secondary Outcomes (8)

• The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.

  Study day 90

• Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.

  Study day 90

• Time to Renal Recovery

  Study day 90

• Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension

  Study day 90

• Number of Participants Enrolled Per Month

  Total study duration, anticipated 1 year

Study Arms (1)

ORKID Bundled Intervention

EXPERIMENTAL

Other: ORKID Bundled Intervention; Drug: Furosemide

Interventions

ORKID Bundled Intervention OTHER

During the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure \> 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure \< 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol.

ORKID Bundled Intervention

Furosemide DRUG

160 mg oral furosemide twice daily to be taken every day at home

ORKID Bundled Intervention

Eligibility Criteria

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

You may qualify if:

• AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team
• Age ≥ 18 years
• Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2
• Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)

You may not qualify if:

• Known loop diuretic allergy/intolerance
• Dialysis duration \> 3 months
• Pregnant
• Prisoner
• Unable to consent
• Clinical team declines to allow approach for study

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Furosemide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Ian McCoy
• Organization: University of California, San Francisco

ian.mccoy@ucsf.edu

415-476-2172

Study Officials

• Ian McCoy, MD, MS

  University of California, San Franisco

  PRINCIPAL INVESTIGATOR

• Chi-yuan Hsu, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center (multi-clinic), non-randomized pilot study to investigate the feasibility, tolerability, and safety of a bundled intervention (cooled dialysate, high sodium dialysate, high dose diuretics, high ultrafiltration hold threshold, active dialysis weaning) designed to foster recovery from acute kidney injury requiring dialysis.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 15, 2021
• Study Start: October 18, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: May 12, 2023
• Results First Posted: May 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)