Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Acute Kidney Injury Clinical Trial

— ORKID  

Official title:

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05158153
• Other study ID #: 21-33602
• Status: Terminated
• Phase: Phase 4
• Start date: October 18, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Dialysis Hypotension
• Hypotension
• Wounds and Injuries

Intervention

Other:
• 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.

Drug:
• Furosemide
160 mg oral furosemide twice daily to be taken every day at home

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First two weeks of study intervention
Secondary	The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.	Tolerability	Study day 90
Secondary	Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.	Safety	Study day 90
Secondary	Time to Renal Recovery	Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.	Study day 90
Secondary	Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension	Defined as nadir systolic blood pressure < 90 mmHg.	Study day 90
Secondary	Number of Participants Enrolled Per Month	Recruitment rate	Total study duration, anticipated 1 year
Secondary	Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled	Screening-to-recruitment ratio	Total study duration, anticipated 1 year
Secondary	Modified Dialysis Symptom Index Score		Study day 0, 7, 14, 28, and 90
Secondary	Kidney Disease Quality of Life-36 Score		Study day 0, 7, 14, 28, and 90