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Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI)

Primary Purpose

Acute Kidney Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conservative dialysis strategy
TIW dialysis strategy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Dialysis-requiring Acute Kidney Injury, Renal Recovery

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
  • If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
  • If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
  • Not requiring vasopressor support
  • Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
  • Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment

Exclusion Criteria:

  • Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
  • Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
  • Liver transplant unit patients
  • Patients who underwent kidney transplantation during index hospitalization
  • Cause of AKI-D is complete nephrectomy
  • Current pregnancy

Sites / Locations

  • UCSF Medical Center Moffitt-Long Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TIW Dialysis Strategy

Conservative Dialysis Strategy

Arm Description

Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.

Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.

Outcomes

Primary Outcome Measures

Protocol adherence [feasibility measure]
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Number of participants with adverse events in each arm [safety measure]
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment

Secondary Outcome Measures

Patient-reported symptoms
Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
Hospital length of stay
Length of inpatient admission, starting after study enrollment
Recovery status at 30, 60, and 90 days after dialysis initiation
Assessment of recovery status via phone call or e-mail contact
Screen-to-enroll ratio [feasibility measure]
Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study

Full Information

First Posted
September 29, 2017
Last Updated
November 14, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03305549
Brief Title
Recovery After Dialysis-Requiring Acute Kidney Injury
Acronym
RAD-AKI
Official Title
Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Study stopped because sufficient pilot data collected to proceed to next clinical trial.
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
Detailed Description
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery. The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Dialysis-requiring Acute Kidney Injury, Renal Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIW Dialysis Strategy
Arm Type
Active Comparator
Arm Description
Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
Arm Title
Conservative Dialysis Strategy
Arm Type
Experimental
Arm Description
Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.
Intervention Type
Other
Intervention Name(s)
Conservative dialysis strategy
Intervention Description
Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm): Blood urea nitrogen >112 mg/dL (40 mmol/L) Serum potassium concentration >6 mmol/L Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate) Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy
Intervention Type
Other
Intervention Name(s)
TIW dialysis strategy
Intervention Description
Thrice-weekly acute intermittent hemodialysis schedule.
Primary Outcome Measure Information:
Title
Protocol adherence [feasibility measure]
Description
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Time Frame
Through completion of active study participation (anticipated <2 weeks for each participant)
Title
Number of participants with adverse events in each arm [safety measure]
Description
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
Time Frame
Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary Outcome Measure Information:
Title
Patient-reported symptoms
Description
Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
Time Frame
Through completion of active study participation (anticipated <2 weeks for each participant)
Title
Hospital length of stay
Description
Length of inpatient admission, starting after study enrollment
Time Frame
Through completion of active study participation (anticipated <2 weeks for each participant)
Title
Recovery status at 30, 60, and 90 days after dialysis initiation
Description
Assessment of recovery status via phone call or e-mail contact
Time Frame
From enrollment to 90 days after dialysis initiation for each patient
Title
Screen-to-enroll ratio [feasibility measure]
Description
Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
Time Frame
Through study completion (anticipated 2 years total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site. If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment. Not requiring vasopressor support Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment Exclusion Criteria: Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2 Liver transplant unit patients Patients who underwent kidney transplantation during index hospitalization Cause of AKI-D is complete nephrectomy Current pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-yuan Hsu, MD, MSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Liu, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Medical Center Moffitt-Long Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Recovery After Dialysis-Requiring Acute Kidney Injury

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