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

This study is currently recruiting participants.
Verified January 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alere San Diego
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01557361
First received: March 13, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Acute Kidney Injury
 Other: Accelerated RRT initiation
Other: Standard RRT initiation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Feasibility of protocol adherence [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    >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


Secondary Outcome Measures:
  • Feasibility of enrollment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    >50% of eligible patients are successfully enrolled in the trial

  • Feasibility of 90-day follow-up [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Vital status and need for RRT at 90 days are successfully captured in >95% of participants

  • Safety outcomes [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Experimental: Accelerated RRT initiation
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557361

Contacts
Contact: Karen L Pope, MSc 416-864-6060 ext 7853 PopeK@smh.ca
Contact: Judith Hall, MSc 416-864-6060 ext 7121 HallJu@smh.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sean M Bagshaw, MD MSc     780-407-6755     bagshaw@ualberta.ca    
Principal Investigator: Sean M Bagshaw, MD MSc            
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: France Clarke         clarkef@mcmaster.ca    
Principal Investigator: Mark Soth, MD            
Sub-Investigator: Deborah Cook, MD MSc            
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6C 6B5
Contact: Matthew Weir, MD         Matthew.Weir@lhsc.on.ca    
Principal Investigator: Matthew Weir, MD            
Sub-Investigator: Andrew House, MD            
London Health Sciences Centre - Victoria Hospital Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Matthew Weir, MD            
Sub-Investigator: Amit Garg, MD PhD            
Principal Investigator: Matthew Weir, MD            
The Ottawa Hospital, Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Tracy McArdle         tmcardle@ohri.ca    
Principal Investigator: Lauralyn McIntyre, MD            
The Ottawa Hospital, General Campus Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Rebecca Porteous         rporteous@ottawahospital.on.ca    
Principal Investigator: Lauralyn McIntyre, MD            
Sub-Investigator: Swapnil Hiremath, MD            
Sub-Investigator: Edward Clark, MD            
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Rottem Kuint, MD         RKuint@mtsinai.on.ca    
Principal Investigator: Stephen Lapinsky, MB, BCh, MSc            
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ron Wald, MDCM MPH     416-867-3703     WaldR@smh.ca    
Principal Investigator: Ron Wald, MDCM MPH            
Sub-Investigator: Karen EA Burns, MD MSc            
Sub-Investigator: Jan Friedrich, MD            
Sub-Investigator: David Klein, MD            
Sub-Investigator: David Mazer, MD            
Sub-Investigator: Orla Smith, RN            
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Neill Adhikari, MDCM MSc         neill.adhikari@sunnybrook.ca    
Contact: Nicole Marinoff         nicole.marinoff@sunnybrook.ca    
Principal Investigator: Neill Adhikari, MDCM MSc            
Sub-Investigator: Michelle Hladunewich, MD            
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Paulina Farias         Paulina.Farias@uhn.on.ca    
Principal Investigator: Margaret Herridge, MD MPH MSc            
Sub-Investigator: Robert Richardson, MD            
Canada, Quebec
Centre hopitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Francois Lamontagne, MD         francois.lamontagne@usherbrooke.ca    
Principal Investigator: Francois Lamontagne, MDCM            
Sub-Investigator: Jean-Francois Bilodeau, MD            
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Alere San Diego
Investigators
Principal Investigator: Ron Wald, MDCM MPH St. Michael's Hospital, Toronto
Principal Investigator: Sean M Bagshaw, MD MSc University of Alberta
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01557361     History of Changes
Other Study ID Numbers: CIHR MOP 111116
Study First Received: March 13, 2012
Last Updated: January 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
renal replacement therapy
dialysis
acute kidney injury
hemodialysis
critical illness

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013