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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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)
Secondary ID [1] 0 0
AHFMR-0920
Universal Trial Number (UTN)
Trial acronym
SPARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Worsening AKI
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Fluid balance
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Renal replacement therapy (RRT)
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Renal Recovery
Timepoint [3] 0 0
90-days
Secondary outcome [4] 0 0
Survival
Timepoint [4] 0 0
90-days

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4012 - Brisbane
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Hospital, Melbourne Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00978354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sean M Bagshaw, MD MSc
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00978354