Clinical trial NCT05158153
Conditions: Acute Kidney Injury Dialysis Hypotension
Keywords: Dialysis-requiring Acute Kidney Injury Renal Recovery
Sponsor: University of California, San Francisco
Start date: 2021-10-18; Completion date: 2022-04-19
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ORKID Bundled Intervention intervention 2: Furosemide
Intervention descriptions: intervention 1: 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 2: 160 mg oral furosemide twice daily to be taken every day at home

Protocol documents:
Prot_SAP_000.pdf: 
Title: Outpatient Recovery from acute Kidney Injury requiring Dialysis (ORKID) 
NCT Number: NCT05158153 
Date: 4/17/23 
 


Outpatient Recovery from acute Kidney Injury requiring Dialysis (ORKID) Protocol 
 
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. This 
is a single-center (multi-clinic), single-arm, 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.  
 
Inclusion Criteria: 
§ AKI-D, 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, or Unable to consent 
§ Clinical team declines to allow approach for study 
 
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. 
Outcomes:  
§ Primary: Feasibility – 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. 
§ Secondary: Tolerability - the proportion of enrolled patients completing the 90-day 
study still continuing each intervention. Safety - Incidence of adverse events including 
electrolyte abnormalities, emergent dialysis treatments, and hospitalizations. Time to 
renal recovery - Days after study enrollment before renal recovery, defined as being 
alive and off dialysis for 14 consecutive days. Intradialytic hypotension – proportion of 
dialysis sessions with nadir systolic blood pressure < 90 mmHg. Recruitment rate - 
number of participants enrolled per month. Screening-to-recruitment ratio - ratio of the 
number of participants who meet inclusion criteria to the number of participants 
enrolled. Modified dialysis symptom index score. Kidney disease quality of life-36 score. 
 


Statistical Analysis Plan: We will perform descriptive statistics on the outcome variables.