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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

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
Secondary outcome [4] 0 0
Timepoint [4] 0 0

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

- Achieved immediate resuscitation goals
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0

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

Ethics approval
Ethics application status

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

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
Trial related presentations / publications
Public notes

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