Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Launched by UNITY HEALTH TORONTO · Oct 4, 2015
Trial Information
Current as of July 09, 2025
Completed
Keywords
ClinConnect Summary
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 th...
Gender
ALL
Eligibility 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
About Unity Health Toronto
Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Birmingham, Alabama, United States
Providence, Rhode Island, United States
Edmonton, Alberta, Canada
Tampere, , Finland
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Coburg, , Germany
Providence, Rhode Island, United States
Christchurch, , New Zealand
London, , United Kingdom
Lausanne, , Switzerland
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Gainesville, Florida, United States
Melbourne, Victoria, Australia
Sydney, , Australia
Toronto, Ontario, Canada
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Ottawa, Ontario, Canada
Dublin, , Ireland
Woolloongabba, , Australia
Edmonton, Alberta, Canada
Sydney, New South Wales, Australia
Kingston, Ontario, Canada
Helsinki, , Finland
Victoria, British Columbia, Canada
Victoria, British Columbia, Canada
Toronto, Ontario, Canada
Hamilton, Ontario, Canada
Beijing, , China
Montreal, Quebec, Canada
London, Ontario, Canada
Wellington, , New Zealand
Melbourne, , Australia
Hastings, , New Zealand
Calgary, Alberta, Canada
Münster, , Germany
Sydney, , Australia
Graz, , Austria
Turku, , Finland
Epping, , Australia
Colombes, , France
Ottawa, Ontario, Canada
Geelong, , Australia
Milano, , Italy
Sydney, , Australia
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Nottingham, , United Kingdom
Aylesbury, , United Kingdom
Ghent, , Belgium
Innsbruck, , Austria
Bendigo, , Australia
Zhengzhou, , China
Edmonton, Alberta, Canada
Edegem, , Belgium
St. Albert, Alberta, Canada
Sudbury, Ontario, Canada
Red Deer, Alberta, Canada
Orpington, , United Kingdom
Xiamen, , China
High Wycombe, , United Kingdom
Wuhan, , China
Heidelberg, , Australia
Concord, , Australia
Changsha, , China
Jinan, , China
Oshawa, Ontario, Canada
Hamilton, Ontario, Canada
Beijing, , China
Rotorua, , New Zealand
Changchun, , China
London, Uk, United Kingdom
Lexington, Kentucky, United States
Ballarat, , Australia
Bedford Park, , Australia
Box Hill, , Australia
Kingswood, , Australia
Nambour, , Australia
St Albans, , Australia
Wien, , Austria
Rio Branco, , Brazil
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland And Labrador, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Mississauga, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Quebec City, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Guiyang, , China
Nanjing, , China
Wuhan, , China
Xi'an, , China
Grafton, Auckland, New Zealand
Auckland, , New Zealand
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Ron Wald, MDCM MPH
Principal Investigator
Unity Health Toronto
Sean M Bagshaw, MD MSc
Principal Investigator
University of Alberta
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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