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Furosemide in Early Acute Kidney Injury (SPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978354
Recruitment Status : Terminated (Feasibility of target enrollment within the context of available funding resources.)
First Posted : September 16, 2009
Last Update Posted : September 30, 2015
Austin Hospital, Melbourne Australia
Princess Alexandra Hospital, Brisbane, Australia
Information provided by (Responsible Party):
Sean M Bagshaw, University of Alberta

Brief Summary:

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:

  1. 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.
  2. 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.
  3. 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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Drug: Furosemide Drug: Normal Saline Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : September 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Furosemide
Furosemide intravenous continuous infusion
Drug: Furosemide
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

Primary Outcome Measures :
  1. Worsening AKI [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Fluid balance [ Time Frame: 7 days ]
  2. Renal replacement therapy (RRT) [ Time Frame: 7 days ]
  3. Renal Recovery [ Time Frame: 90-days ]
  4. Survival [ Time Frame: 90-days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed and written consent by patient or surrogate
  • Peripheral or central intravenous catheter
  • The presence of early AKI
  • 2 or more criteria for the systemic inflammatory response syndrome (SIRS) within 24 hours
  • Achieved immediate resuscitation goals

Exclusion Criteria:

  • Confirmed or suspected pregnancy
  • Age <18 years
  • Stage 4 or greater chronic kidney disease or kidney transplantation
  • Acute pulmonary edema requiring urgent use of furosemide or RRT
  • Patient is moribund with expected death within 24 hours
  • Known or suspected drug allergy to furosemide
  • Enrolled in concomitant randomized trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00978354

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Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4012
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3084
Canada, Alberta
General Systems Intensive Care Unit, University of Alberta
Edmonton, Alberta, Canada, T6G2B7
Canada, Quebec
University of Laval
Quebec City, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
University of Alberta
Austin Hospital, Melbourne Australia
Princess Alexandra Hospital, Brisbane, Australia
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Principal Investigator: Sean M Bagshaw, MD MSc University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sean M Bagshaw, Associate Professor, University of Alberta Identifier: NCT00978354     History of Changes
Other Study ID Numbers: AHFMR-0920
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Sean M Bagshaw, University of Alberta:
acute kidney injury
acute renal failure
loop diuretic
critical illness
renal replacement therapy
renal recovery
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action