Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Phase 4

Terminated

• Conditions: Acute Kidney Injury; Dialysis Hypotension
• Interventions: Other: ORKID Bundled Intervention; Drug: Furosemide

• Registration Number: NCT05158153
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-15
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Status Verified: 2023-04
• Results First Submitted: 2023-04-18
• Results First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Results First Posted: 2023-05-12
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ORKID Bundled Intervention	Furosemide	-
ORKID Bundled Intervention	ORKID Bundled Intervention	-

Primary Outcome Measures

Name	Time	Method
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.	First two weeks of study intervention	Feasibility

Secondary Outcome Measures

Name	Time	Method
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.	Study day 90	Tolerability
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	Safety
Time to Renal Recovery	Study day 90	Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension	Study day 90	Defined as nadir systolic blood pressure \< 90 mmHg.
Number of Participants Enrolled Per Month	Total study duration, anticipated 1 year	Recruitment rate
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled	Total study duration, anticipated 1 year	Screening-to-recruitment ratio
Modified Dialysis Symptom Index Score	Study day 0, 7, 14, 28, and 90
Kidney Disease Quality of Life-36 Score	Study day 0, 7, 14, 28, and 90

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States