ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02568722
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02568722
Recruitment Status : Recruiting
First Posted : October 6, 2015
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
The George Institute
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Standard RRT initiation Other: Accelerated RRT initiation Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 2866 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
Study Start Date : October 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.
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.


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.
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.




Primary Outcome Measures :
  1. All-cause mortality. [ Time Frame: 90 days following study randomization. ]

Secondary Outcome Measures :
  1. RRT dependence [ Time Frame: 90 days following study randomization. ]
  2. Composite of death or RRT dependence. [ Time Frame: 90 days following study randomization. ]
  3. Measurement of estimated glomerular filtration rate. [ Time Frame: 90 days following study randomization. ]
  4. Measurement of albuminuria. [ Time Frame: 90 days following study randomization. ]
  5. 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).

  6. Mechanical ventilation-free days. [ Time Frame: Measured from randomization through day 28. ]
  7. Vasoactive therapy-free days [ Time Frame: Measured from randomization through day 28. ]
  8. ICU-free days [ Time Frame: Measured from randomization through day 28. ]
  9. Hospitalization-free days [ Time Frame: Measured from randomization through day 90. ]
  10. Death in ICU [ Time Frame: Measured in-hospital and at day 28. ]
  11. 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.

  12. Health care costs. [ Time Frame: Measured from baseline through day 365. ]
  13. Composite of death or RRT dependence. [ Time Frame: Measured at day 365. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02568722


Contacts
Contact: Nikita Chavda, BSc ChavdaN@smh.ca

  Show 111 Study Locations
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Baxter Healthcare Corporation
The George Institute
Investigators
Principal Investigator: Ron Wald, MDCM MPH St. Michael's Hospital, Toronto
Principal Investigator: Sean M Bagshaw, MD MSc University of Alberta

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02568722     History of Changes
Other Study ID Numbers: STARRT-AKI: Principal Trial
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by St. Michael's Hospital, Toronto:
Renal replacement therapy
Acute kidney injury
Dialysis
Hemodialysis
Critical illness

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