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Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568722
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
The George Institute
National Institute for Health Research, United Kingdom
Medical Research Institute of New Zealand
Health Research Council, New Zealand
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2015)
All-cause mortality. [ Time Frame: 90 days following study randomization. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2015)
  • RRT dependence [ Time Frame: 90 days following study randomization. ]
  • Composite of death or RRT dependence. [ Time Frame: 90 days following study randomization. ]
  • Measurement of estimated glomerular filtration rate. [ Time Frame: 90 days following study randomization. ]
  • Measurement of albuminuria. [ Time Frame: 90 days following study randomization. ]
  • Major adverse kidney outcomes. [ Time Frame: 90 days following study randomization. ]
    Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR).
  • Mechanical ventilation-free days. [ Time Frame: Measured from randomization through day 28. ]
  • Vasoactive therapy-free days [ Time Frame: Measured from randomization through day 28. ]
  • ICU-free days [ Time Frame: Measured from randomization through day 28. ]
  • Hospitalization-free days [ Time Frame: Measured from randomization through day 90. ]
  • Death in ICU [ Time Frame: Measured in-hospital and at day 28. ]
  • EuroQoL EQ-5D-5L. [ Time Frame: Measured at day 90 and at day 365. ]
    A measure of health-related quality of life and patient utility.
  • Health care costs. [ Time Frame: Measured from baseline through day 365. ]
  • Composite of death or RRT dependence. [ Time Frame: Measured at day 365. ]
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 Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Official Title  ICMJE STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
Brief Summary

The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

  1. Improved survival (primary outcome); and
  2. Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
Detailed Description Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • Other: Standard RRT initiation

    In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:

    serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI > 72 hours following the time of randomization.

  • Other: Accelerated RRT initiation
    A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
Study Arms  ICMJE
  • Active Comparator: Standard RRT initiation
    RRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
    Intervention: Other: Standard RRT initiation
  • Experimental: Accelerated RRT initiation
    A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
    Intervention: Other: Accelerated RRT initiation
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
3019
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2015)
2866
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Admission to an intensive care unit (ICU)
  3. Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)]
  4. Evidence of severe AKI defined by at least 1 of the following 3 criteria:

    i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output < 6.0 mL/kg over the preceding 12 hours

Exclusion Criteria:

  1. Serum potassium > 5.5 mmol/L
  2. Serum bicarbonate < 15 mmol/L
  3. Presence of a drug overdose that necessitates initiation of RRT
  4. Lack of commitment to ongoing life support (including RRT)
  5. Any RRT within the previous 2 months (either acute or chronic RRT)
  6. Kidney transplant within the past 365 days
  7. Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2
  8. Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
  9. Clinician(s) caring for patient believe(s) that immediate RRT is mandated
  10. Clinician(s) caring for patient believe(s) that deferral of RRT initiation is mandated

    • at their discretion, clinicians may administer a bolus of intravenous furosemide (ie, "furosemide stress test") and evaluate the subsequent urine output to help guide decision making regarding the likelihood of AKI progression
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Finland,   France,   Germany,   Ireland,   Italy,   New Zealand,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568722
Other Study ID Numbers  ICMJE STARRT-AKI: Principal Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • National Health and Medical Research Council, Australia
  • Baxter Healthcare Corporation
  • The George Institute
  • National Institute for Health Research, United Kingdom
  • Medical Research Institute of New Zealand
  • Health Research Council, New Zealand
Investigators  ICMJE
Principal Investigator: Ron Wald, MDCM MPH St. Michael's Hospital, Toronto
Principal Investigator: Sean M Bagshaw, MD MSc University of Alberta
PRS Account St. Michael's Hospital, Toronto
Verification Date January 2020

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