ORKID: Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Sponsor

University of California, San Francisco (Other)

Overall Status

Terminated

CT.gov ID

NCT05158153

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Dialysis Hypotension	Other: ORKID Bundled Intervention Drug: Furosemide	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Actual Study Start Date :

Oct 18, 2021

Actual Primary Completion Date :

Apr 19, 2022

Actual Study Completion Date :

Apr 19, 2022

Arms and Interventions

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

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

Outcome Measures

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. [First two weeks of study intervention]
Feasibility

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

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