Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Phase 4TerminatedNCT05158153

University of California, San Francisco1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury Dialysis Hypotension

Interventions

ORKID Bundled InterventionOTHER

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.

FurosemideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

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

Time frame: First two weeks of study intervention

Secondary Outcomes

The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.

Tolerability

Time frame: 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

Time frame: 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.

Time frame: Study day 90

Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension

Defined as nadir systolic blood pressure \< 90 mmHg.

Time frame: Study day 90

Number of Participants Enrolled Per Month

Recruitment rate

Time frame: 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

Time frame: Total study duration, anticipated 1 year

Data from ClinicalTrials.gov

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