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Clinical Trials/NCT05158153
NCT05158153
Terminated
Phase 4

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

University of California, San Francisco1 site in 1 country1 target enrollmentOctober 18, 2021

Overview

Phase
Phase 4
Intervention
ORKID Bundled Intervention
Conditions
Acute Kidney Injury
Sponsor
University of California, San Francisco
Enrollment
1
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2021
End Date
April 19, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Unable to consent
  • Clinical team declines to allow approach for study

Arms & Interventions

ORKID Bundled Intervention

Intervention: ORKID Bundled Intervention

ORKID Bundled Intervention

Intervention: Furosemide

Outcomes

Primary Outcomes

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.

Time Frame: First two weeks of study intervention

Feasibility

Secondary Outcomes

  • 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)
  • Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled(Total study duration, anticipated 1 year)
  • 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)

Study Sites (1)

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