Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury (STARRT-AKI)

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: NCT01557361
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : September 12, 2014
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alere San Diego
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 19, 2012
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Feasibility of protocol adherence [ Time Frame: 14 days ]
>90% of participants in the accelerated initiation arm start RRT within 12 hours of eligibility AND >90% of participants randomized to the standard initiation arm who ultimately receive RRT, start RRT at least 12 hours following eligibility determination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01557361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Feasibility of enrollment [ Time Frame: 14 days ]
    >50% of eligible patients are successfully enrolled in the trial
  • Feasibility of 90-day follow-up [ Time Frame: 90 days ]
    Vital status and need for RRT at 90 days are successfully captured in >95% of participants
  • Safety outcomes [ Time Frame: 14 days ]
    Serious adverse effects, with a particular focus on those that are potentially attributable to the study treatment, vascular accesss complications (including hemorrhage, thrombosis and infection) and complications associated with the delivery of RRT (dialysis-associated hypotension, electrolyte abnormalities) will be examined.
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 Versus Accelerated Initiation of Dialysis in Acute Kidney Injury
Official Title  ICMJE STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)
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 with standard initiation, is:

  1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
  2. Safe, from the perspective of potential adverse events associated with earlier initiation of RRT
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%. Delay in the initiation of RRT has been implicated as a possible contributor to this poor outcome. A recent meta-analysis suggested that earlier initiation of RRT may improve survival. However, completed trials to date have been small, single centre, limited by study quality, and have shown considerable heterogeneity in terms of definitions used for "early" RRT initiation.

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 with standard initiation, is:

  1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
  2. Safe, from the perspective of potential adverse events associated with the earlier or later initiation of RRT

This pilot trial is intended to guide and inform the design of a phase III multicentre randomized trial of accelerated versus standard initiation of RRT in critically ill patients that will evaluate the impact of the intervention on 90-day all-cause mortality and recovery of kidney function.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • 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.
  • Other: Standard RRT initiation

    Patients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are:

    I. Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND

    II. At least one of the following indications for RRT initiation:

    1. Serum potassium ≥6.0 mmol/L, or
    2. Serum bicarbonate ≤ 10 mmol/L, or
    3. Evidence of severe respiratory failure, based on a PaO2/FiO2 <200 and bilateral infiltrates on the chest x-ray, or
    4. By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization
Study Arms  ICMJE
  • Active Comparator: Standard RRT initiation
    RRT is initiated >12 hours after eligibility determination. Once a decision is made to start RRT, a dialysis catheter will be placed and RRT initiated as soon as possible.
    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 eligibility.
    Intervention: Other: Accelerated RRT initiation
Publications * Smith OM, Wald R, Adhikari NK, Pope K, Weir MA, Bagshaw SM; Canadian Critical Care Trials Group. Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial. Trials. 2013 Oct 5;14:320. doi: 10.1186/1745-6215-14-320.

*   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: March 15, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (all of these need to be present):

  1. Age ≥ 18 years
  2. Admission to an intensive care unit
  3. Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or

    ≥ 130 µmol/L (men))

  4. Evidence of severe AKI defined by at least 2 of the following 3 criteria:

    i-A 2-fold increase in serum creatinine during hospitalization or from a known pre-hospitalization baseline ii-Oliguria as defined by total urine output < 6 mL/kg over the preceding 12 hours iii-Whole blood Neutrophil Gelatinase-Associated Lipocalin (NGAL) ≥ 400ng/mL

  5. Likelihood that an absolute indication for RRT will not arise in the subsequent 24 hours based on the most recent bloodwork for the following parameters: i- Serum potassium ≤ 5.5 mmol/L and ii- Serum bicarbonate ≥ 15 mmol/L
  6. Central venous pressure ≥ 8 mmHg

Exclusion Criteria (the presence of one of these would disqualify eligibility):

  1. Lack of commitment to ongoing life support
  2. Presence of a drug overdose that necessitates initiation of RRT
  3. Any RRT within the previous 2 months
  4. Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
  5. Advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 30 mL/min/1.73 m2, based on pre-hospitalization blood work
  6. Kidney transplant within the past 365 days
  7. At the time of screening, doubling of serum creatinine has been present for > 48 hours
  8. Clinician(s) caring for patient believe(s) that immediate dialysis is absolutely mandated
  9. Clinician(s) caring for patient believe(s) that deferral of dialysis initiation is mandated
  10. Patient or substitute decision maker can not provide consent within 12 hours of study eligibility
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01557361
Other Study ID Numbers  ICMJE CIHR MOP 111116
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)
  • Alere San Diego
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 August 2013

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