The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury.
BACKGROUND
Furosemide is commonly prescribed in critically ill patients with acute kidney injury (AKI). Existing data from observational studies and small clinical trials have significant limitations and have reported conflicting findings. There remains controversy on whether furosemide can impact clinical outcomes in critically ill patients with AKI; however, a survey of intensivists and nephrologists showed equipoise for high-quality evidence on this important issue.


METHODS
This protocol summarizes the rationale and design of a phase II randomized, blinded, placebo-controlled trial of a low-dose continuous infusion of furosemide, titrated to the physiology parameter of urine output, in critically ill patients with early AKI. Two hundred sixteen adult critically ill patients with early evidence of AKI, defined by the RIFLE criteria, will be enrolled. Included patients will also have fulfilled >or=2 criteria of the systemic inflammatory response syndrome and achieved immediate goals of acute resuscitation. The primary outcome is progression in severity of kidney injury. Secondary outcomes include: safety, fluid balance, electrolyte balance, the need for renal replacement therapy, duration of AKI, rate of renal recovery, mortality and changes in novel serum and urine biomarkers of AKI. The primary analysis will be intention-to-treat. Planned recruitment will be complete by June 2011 and results available by December 2011.


BACKGROUND
ClinicalTrials.gov Identifier NCT00978354.
Bagshaw
Sean M
SM
Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta,12 Walter C, Mackenzie Centre, 8440-112 Street, Edmonton, Alberta, Canada. bagshaw@ualberta.ca
Gibney
R T Noel
RT
McAlister
Finlay A
FA
Bellomo
Rinaldo
R
D000208:Acute Disease; D000328:Adult; D000416:Alberta; D015415:Biomarkers / Q000097:blood / Q000652:urine; D016638:Critical Illness; D018450:Disease Progression; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005665:Furosemide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D008297:Male; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome
D015415:Biomarkers; D004232:Diuretics; D005665:Furosemide
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