Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Completed · Not applicable
Conditions studied: Acute Kidney Injury
In brief
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
Key facts
- Study ID
- NCT02568722
- Run by
- Unity Health Toronto
- People needed
- 3019
- Starts
- 2015-10-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2024-10-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Admission to an intensive care unit (ICU)
- Evidence of kidney dysfunction [serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)]
- 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
You may not qualify if…
- Serum potassium > 5.5 mmol/L
- Serum bicarbonate < 15 mmol/L
- Presence of a drug overdose that necessitates initiation of RRT
- Lack of commitment to ongoing life support (including RRT)
- Any RRT within the previous 2 months (either acute or chronic RRT)
- Kidney transplant within the past 365 days
- Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 20 mL/min/1.73 m2
- Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
- Clinician(s) caring for patient believe(s) that immediate RRT is mandated
- 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
Where it is running
- University of Florida — Gainesville, Florida, United States
- University of Kentucy — Lexington, Kentucky, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- The Miriam Hospital — Providence, Rhode Island, United States
- Ballarat Hospital — Ballarat, Australia
- Flinder Medical Centre — Bedford Park, Australia
- Bendigo Hospital — Bendigo, Australia
- Eastern Hospital (Box Hill and Maroondah Hospital) — Box Hill, Australia
- Concord Hospital — Concord, Australia
- The Northern Hospital — Epping, Australia
- Geelong Hospital — Geelong, Australia
- Austin Hospital — Heidelberg, Australia
- Nepean Hospital — Kingswood, Australia
- The Alfred Hospital — Melbourne, Australia
- Nambour General Hospital — Nambour, Australia
- Western Health (Footscray Hospital & Sunshine Hospital) — St Albans, Australia
- St. Vincent's Hospital — Sydney, Australia
- Royal North Shore Hospital — Sydney, Australia
- Royal Prince Alfred Hospital — Sydney, Australia
- Princess Alexandra Hospital — Woolloongabba, Australia
- Medical University Graz — Graz, Austria
- Medical University Innsbruck — Innsbruck, Austria
- Vienna General Hospital — Vienna, Austria
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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