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

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ClinicalTrials.gov Identifier: NCT03305549
Recruitment Status : Terminated (Study stopped because sufficient pilot data collected to proceed to next clinical trial.)
First Posted : October 10, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 29, 2017
First Posted Date  ICMJE October 10, 2017
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE September 29, 2017
Actual Primary Completion Date November 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • Protocol adherence [feasibility measure] [ Time Frame: Through completion of active study participation (anticipated <2 weeks for each participant) ]
    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] [ Time Frame: Through completion of active study participation (anticipated <2 weeks for each participant) ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03305549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • Patient-reported symptoms [ Time Frame: Through completion of active study participation (anticipated <2 weeks for each participant) ]
    Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
  • Hospital length of stay [ Time Frame: Through completion of active study participation (anticipated <2 weeks for each participant) ]
    Length of inpatient admission, starting after study enrollment
  • Recovery status at 30, 60, and 90 days after dialysis initiation [ Time Frame: From enrollment to 90 days after dialysis initiation for each patient ]
    Assessment of recovery status via phone call or e-mail contact
  • Screen-to-enroll ratio [feasibility measure] [ Time Frame: Through study completion (anticipated 2 years total) ]
    Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recovery After Dialysis-Requiring Acute Kidney Injury
Official Title  ICMJE Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • Other: Conservative dialysis strategy

    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
  • Other: TIW dialysis strategy
    Thrice-weekly acute intermittent hemodialysis schedule.
Study Arms  ICMJE
  • Active Comparator: TIW Dialysis Strategy
    Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
    Intervention: Other: TIW dialysis strategy
  • Experimental: Conservative Dialysis Strategy
    Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.
    Intervention: Other: Conservative dialysis strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 14, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2017)
20
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date November 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03305549
Other Study ID Numbers  ICMJE F32DK115030( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chi-yuan Hsu, MD, MSc University of California, San Francisco
Principal Investigator: Kathleen Liu, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP