Clinical trial NCT05158153: Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Official title: Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Kidney Injury
Dialysis Hypotension
Keywords: Dialysis-requiring Acute Kidney Injury
Renal Recovery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: First two weeks of study intervention
Secondary outcomes:
measure: The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
timeFrame: Study day 90
measure: Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
timeFrame: Study day 90
measure: Time to Renal Recovery
timeFrame: Study day 90
measure: Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension
timeFrame: Study day 90
measure: Number of Participants Enrolled Per Month
timeFrame: Total study duration, anticipated 1 year
measure: Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
timeFrame: Total study duration, anticipated 1 year
measure: Modified Dialysis Symptom Index Score
timeFrame: Study day 0, 7, 14, 28, and 90
measure: Kidney Disease Quality of Life-36 Score
timeFrame: Study day 0, 7, 14, 28, and 90
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Franisco
name: Ian McCoy, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Chi-yuan Hsu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: