Clinical trial

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Name

21-33602

Description

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.

Trial arms

Trial start

2021-10-18

Estimated PCD

2022-04-19

Trial end

2022-04-19

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

ORKID Bundled Intervention

Furosemide

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

Arms:

ORKID Bundled Intervention

Size

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.

First two weeks of study intervention

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-05-12

1 organization

1 product

2 indications

Organization

University of California, San Francisco

Product

Furosemide

Indication

Acute Kidney Injury

Indication

Hypotension