Furosemide in Early Acute Kidney Injury (SPARK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Collaborators:
Grey Nuns Community Hospital, Edmonton, Canada
Austin Hospital, Melbourne Australia
Princess Alexandra Hospital, Brisbane, Australia
Information provided by (Responsible Party):
Sean Bagshaw, University of Alberta
ClinicalTrials.gov Identifier:
NCT00978354
First received: September 14, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Acute Renal Failure
Drug: Furosemide
Drug: Normal Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Worsening AKI [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluid balance [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Renal replacement therapy (RRT) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Renal Recovery [ Time Frame: 90-days ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 90-days ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: September 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978354

Contacts
Contact: Sean M Bagshaw, MD MSc 780-407-6755 bagshaw@ualberta.ca

Locations
Australia, Queensland
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4012
Contact: Peter Kruger       peter_kruger@health.qld.gov.au   
Principal Investigator: Peter Kruger         
Australia, Victoria
Austin Hospital Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Rinaldo Bellomo       Rinaldo.Bellomo@austin.org.au   
Contact: Glenn Eastwood       Glenn.EASTWOOD@austin.org.au   
Principal Investigator: Rinaldo Bellomo         
Canada, Alberta
General Systems Intensive Care Unit, University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Sean M Bagshaw       bagshaw@ualberta.ca   
Contact: Samantha Taylor    780-407-7448    samantha.taylor@albertahealthservices.ca   
Principal Investigator: Sean M Bagshaw, MD MSc         
Grey Nuns Community Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6L 5X8
Contact: Daniel E Stollery       dstoller@ualberta.ca   
Contact: Jennifer Barchard       Jennifer.barchard@albertahealthservices.ca   
Principal Investigator: Daniel E Stollery         
Sponsors and Collaborators
University of Alberta
Grey Nuns Community Hospital, Edmonton, Canada
Austin Hospital, Melbourne Australia
Princess Alexandra Hospital, Brisbane, Australia
Investigators
Principal Investigator: Sean M Bagshaw, MD MSc University of Alberta
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sean Bagshaw, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00978354     History of Changes
Other Study ID Numbers: AHFMR-0920
Study First Received: September 14, 2009
Last Updated: August 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
acute kidney injury
acute renal failure
loop diuretic
critical illness
sepsis
renal replacement therapy
dialysis
renal recovery
survival

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Wounds and Injuries
Kidney Diseases
Urologic Diseases
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014