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Outpatient Recovery From Acute Kidney Injury Requiring Dialysis (ORKID)

Primary Purpose

Acute Kidney Injury, Dialysis Hypotension

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ORKID Bundled Intervention
Furosemide
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Dialysis-requiring Acute Kidney Injury, Renal Recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ORKID Bundled Intervention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
Tolerability
Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
Safety
Time to Renal Recovery
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
Defined as nadir systolic blood pressure < 90 mmHg.
Number of Participants Enrolled Per Month
Recruitment rate
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
Screening-to-recruitment ratio
Modified Dialysis Symptom Index Score
Kidney Disease Quality of Life-36 Score

Full Information

First Posted
November 19, 2021
Last Updated
April 18, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05158153
Brief Title
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Acronym
ORKID
Official Title
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Dialysis Hypotension
Keywords
Dialysis-requiring Acute Kidney Injury, Renal Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORKID Bundled Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ORKID Bundled Intervention
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
160 mg oral furosemide twice daily to be taken every day at home
Primary Outcome Measure Information:
Title
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.
Description
Feasibility
Time Frame
First two weeks of study intervention
Secondary Outcome Measure Information:
Title
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
Description
Tolerability
Time Frame
Study day 90
Title
Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
Description
Safety
Time Frame
Study day 90
Title
Time to Renal Recovery
Description
Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.
Time Frame
Study day 90
Title
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension
Description
Defined as nadir systolic blood pressure < 90 mmHg.
Time Frame
Study day 90
Title
Number of Participants Enrolled Per Month
Description
Recruitment rate
Time Frame
Total study duration, anticipated 1 year
Title
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
Description
Screening-to-recruitment ratio
Time Frame
Total study duration, anticipated 1 year
Title
Modified Dialysis Symptom Index Score
Time Frame
Study day 0, 7, 14, 28, and 90
Title
Kidney Disease Quality of Life-36 Score
Time Frame
Study day 0, 7, 14, 28, and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pregnant Prisoner Unable to consent Clinical team declines to allow approach for study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian McCoy, MD, MS
Organizational Affiliation
University of California, San Franisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi-yuan Hsu, MD, MSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

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