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Search / Trial NCT02568722

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

Renal Replacement Therapy Acute Kidney Injury Dialysis Hemodialysis Critical Illness

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.

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

0 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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