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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00978354
Registration number
NCT00978354
Ethics application status
Date submitted
14/09/2009
Date registered
16/09/2009
Date last updated
30/09/2015
Titles & IDs
Public title
Furosemide in Early Acute Kidney Injury
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Scientific 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)
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Secondary ID [1]
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AHFMR-0920
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Universal Trial Number (UTN)
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Trial acronym
SPARK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Injuries and Accidents
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Furosemide
Treatment: Drugs - Normal Saline
Active comparator: Furosemide - Furosemide intravenous continuous infusion
Placebo comparator: Normal Saline - Normal saline titrated continuous intravenous infusion
Treatment: Drugs: Furosemide
Continuous intravenous infusion of furosemide titrated to urine output
Treatment: Drugs: Normal Saline
Continuous intravenous infusion 0.9% normal saline placebo control
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Worsening AKI
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Assessment method [1]
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Timepoint [1]
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7 days
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Secondary outcome [1]
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Fluid balance
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Assessment method [1]
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Timepoint [1]
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7 days
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Secondary outcome [2]
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Renal replacement therapy (RRT)
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Assessment method [2]
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0
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Timepoint [2]
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7 days
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Secondary outcome [3]
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Renal Recovery
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Assessment method [3]
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Timepoint [3]
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90-days
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Secondary outcome [4]
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Survival
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Assessment method [4]
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Timepoint [4]
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90-days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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4012 - Brisbane
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Alberta
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Austin Hospital, Melbourne Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Princess Alexandra Hospital, Brisbane, Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00978354
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Trial related presentations / publications
Bagshaw SM, Gibney RTN, Kruger P, Hassan I, McAlister FA, Bellomo R. The effect of low-dose furosemide in critically ill patients with early acute kidney injury: A pilot randomized blinded controlled trial (the SPARK study). J Crit Care. 2017 Dec;42:138-146. doi: 10.1016/j.jcrc.2017.07.030. Epub 2017 Jul 12. Bagshaw SM, Gibney RT, McAlister FA, Bellomo R. The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury. Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
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Public notes
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Contacts
Principal investigator
Name
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Sean M Bagshaw, MD MSc
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Address
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University of Alberta
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00978354
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