Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

NCT ID: NCT05158153

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2022-04-19

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.

Conditions

Acute Kidney Injury; Dialysis Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORKID Bundled Intervention

Group Type: EXPERIMENTAL

ORKID Bundled Intervention

Intervention Type: OTHER

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.

Furosemide

Intervention Type: DRUG

160 mg oral furosemide twice daily to be taken every day at home

Interventions

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.

Intervention Type: OTHER

Furosemide

160 mg oral furosemide twice daily to be taken every day at home

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian McCoy, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Franisco

Chi-yuan Hsu, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-33602

Identifier Type: -

Identifier Source: org_study_id