Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Study Overview
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Brief Summary
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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.

Official Title
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Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

Conditions
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Acute Kidney Injury, Dialysis Hypotension

Intervention / Treatment
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* Other: ORKID Bundled Intervention
* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORKID Bundled Intervention<br> | Other: ORKID Bundled Intervention<br>* 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.<br>Drug: Furosemide<br>* 160 mg oral furosemide twice daily to be taken every day at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention. | Tolerability | 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 | 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. | Study day 90 | 
| Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension | Defined as nadir systolic blood pressure < 90 mmHg. | Study day 90 | 
| Number of Participants Enrolled Per Month | Recruitment rate | 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 | Total study duration, anticipated 1 year | 
| Modified Dialysis Symptom Index Score |  | Study day 0, 7, 14, 28, and 90 | 
| Kidney Disease Quality of Life-36 Score |  | Study day 0, 7, 14, 28, and 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis-requiring Acute Kidney Injury, Renal Recovery