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

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ClinicalTrials.gov Identifier: NCT03305549
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Conservative dialysis strategy Other: TIW dialysis strategy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: TIW Dialysis Strategy
Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
Other: TIW dialysis strategy
Thrice-weekly acute intermittent hemodialysis schedule.

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.
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305549


Locations
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United States, California
UCSF Medical Center Moffitt-Long Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Chi-yuan Hsu, MD, MSc University of California, San Francisco
Principal Investigator: Kathleen Liu, MD, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03305549     History of Changes
Other Study ID Numbers: F32DK115030 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Dialysis-requiring Acute Kidney Injury
Renal Recovery
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases