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The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury.

Bagshaw SM, Gibney RT, McAlister FA, Bellomo R - Trials (2010)

Bottom Line: 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.Planned recruitment will be complete by June 2011 and results available by December 2011.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

Design/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.

Trial registration: ClinicalTrials.gov Identifier NCT00978354.

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Related in: MedlinePlus

Overview of patient flow.
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Related In: Results  -  Collection

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Figure 1: Overview of patient flow.

Mentions: Figure 1 outlines the study flow. Patients will be identified in the ICU by daily surveillance by the research coordinator or when identified by the treating ICU physician. Each patient's eligibility will be verified by use of a one-page checklist that summarizes the inclusion and exclusion criteria. This checklist will be included in the standardized case-report form (CRF).


The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury.

Bagshaw SM, Gibney RT, McAlister FA, Bellomo R - Trials (2010)

Overview of patient flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2874544&req=5

Figure 1: Overview of patient flow.
Mentions: Figure 1 outlines the study flow. Patients will be identified in the ICU by daily surveillance by the research coordinator or when identified by the treating ICU physician. Each patient's eligibility will be verified by use of a one-page checklist that summarizes the inclusion and exclusion criteria. This checklist will be included in the standardized case-report form (CRF).

Bottom Line: 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.Planned recruitment will be complete by June 2011 and results available by December 2011.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

Design/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.

Trial registration: ClinicalTrials.gov Identifier NCT00978354.

Show MeSH
Related in: MedlinePlus