Outpatient Recovery From Acute Kidney Injury Requiring Dialysis (ORKID)

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.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury; Dialysis Hypotension
• Intervention / Treatment: Other: ORKID Bundled Intervention; Drug: Furosemide

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ORKID Bundled Intervention

Other: ORKID Bundled Intervention; 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.; Drug: Furosemide; 160 mg oral furosemide twice daily to be taken every day at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.	Tolerability	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.	Safety	Study day 90
Time to Renal Recovery	Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.	Study day 90
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension	Defined as nadir systolic blood pressure < 90 mmHg.	Study day 90
Number of Participants Enrolled Per Month	Recruitment rate	Total study duration, anticipated 1 year
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled	Screening-to-recruitment ratio	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ian McCoy, MD, MS, University of California, San Franisco; Principal Investigator: Chi-yuan Hsu, MD, MSc, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): April 19, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Dialysis-requiring Acute Kidney Injury; Renal Recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Hypotension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 21-33602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No