Furosemide in Early Acute Kidney Injury (SPARK)
Acute renal failure, now referred to as acute kidney injury, is common in intensive care unit patients, contributes to high morbidity and mortality, and has no proven interventions with benefit once established. In addition to supportive care, these patients frequently receive diuretic therapy, most commonly furosemide.
Prior trials showed no impact of furosemide on clinical outcomes and perhaps harm, however, these trials suffered from numerous limitations and lack applicability to modern intensive care unit patients. As a result, there appears a disconnect between clinical practice and available evidence. Survey data supports the view of clinical equipoise for use of furosemide in intensive care unit patients with early acute kidney injury. Moreover, these data also confirm there is an urgent need for higher quality and more definitive evidence from randomized trial on furosemide use in early acute kidney injury.
Accordingly, the investigators propose to conduct a pilot phase II randomized, blinded, placebo-controlled trial comparing furosemide to placebo in ICU patients with early acute kidney injury.
The specific aims of this study are:
- To compare the efficacy and safety of a continuous infusion of furosemide versus placebo titrated to the physiology parameter of urine output in early acute kidney injury on the primary outcome of progression in severity of kidney injury in intensive care unit patients with early AKI and stratified by the presence of sepsis.
- To evaluate selected secondary endpoints on the impact of furosemide versus placebo, specifically: fluid balance goals; electrolyte and acid-base balance; the need for renal replacement therapy (i.e. dialysis); total duration of acute kidney injury; the rate of renal recovery; and mortality.
- To compare the impact of furosemide versus placebo on the trajectory of serum and urinary biomarkers (neutrophil gelatinase-associated lipocalin [NGAL], interleukin-18 [IL-18]) and evaluate whether these biomarkers perform superior to conventional measures (creatinine, urea) for monitoring the progression of kidney injury and the prediction of outcome.
This trial represents part of a larger initiative aimed towards expanding our understanding of the treatment of acute kidney injury in intensive care unit patients and evaluating interventions that may potentially reduce kidney injury and improve clinical outcomes.
Acute Renal Failure
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized Blinded Controlled Trial of the Effect of furoSemide in Critically Ill Patients With eARly Acute Kidney Injury (The SPARK Study)|
- Worsening AKI [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Fluid balance [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Renal replacement therapy (RRT) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Renal Recovery [ Time Frame: 90-days ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 90-days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Furosemide
Furosemide intravenous continuous infusion
Continuous intravenous infusion of furosemide titrated to urine output
Other Name: Lasix
Placebo Comparator: Normal Saline
Normal saline titrated continuous intravenous infusion
Drug: Normal Saline
Continuous intravenous infusion 0.9% normal saline placebo control
Other Name: 0.9% saline
Show Detailed Description
|Contact: Sean M Bagshaw, MD MScemail@example.com|
|Princess Alexandra Hospital||Recruiting|
|Brisbane, Queensland, Australia, 4012|
|Contact: Peter Kruger firstname.lastname@example.org|
|Principal Investigator: Peter Kruger|
|Melbourne, Victoria, Australia, 3084|
|Contact: Rinaldo Bellomo Rinaldo.Bellomo@austin.org.au|
|Contact: Glenn Eastwood Glenn.EASTWOOD@austin.org.au|
|Principal Investigator: Rinaldo Bellomo|
|General Systems Intensive Care Unit, University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G2B7|
|Contact: Sean M Bagshaw email@example.com|
|Contact: Samantha Taylor 780-407-7448 firstname.lastname@example.org|
|Principal Investigator: Sean M Bagshaw, MD MSc|
|Grey Nuns Community Hospital||Not yet recruiting|
|Edmonton, Alberta, Canada, T6L 5X8|
|Contact: Daniel E Stollery email@example.com|
|Contact: Jennifer Barchard Jennifer.firstname.lastname@example.org|
|Principal Investigator: Daniel E Stollery|
|Principal Investigator:||Sean M Bagshaw, MD MSc||University of Alberta|