Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery. - Full Text View

Sponsor:	Melbourne Health
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00246675

Purpose

The purpose of the project is to test whether or not the commonly used medication frusemide, given after heart surgery, and aiming to increase urinary output can have an effect on kidney function.

Condition	Intervention
Renal Impairment After Cardiac Surgery	Drug: Frusemide

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.

Secondary Outcome Measures:

1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.
2. Incidence of renal failure requiring any form of renal replacement therapy.
3. Duration of post-operative hospital and ICU stay.
4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.

Estimated Enrollment:

400

Detailed Description:

All patients will receive standard supportive care based on current established management practice of cardio-thoracic patients. The only difference in treatment will be the randomisation of patients to receive/not receive protocolised administration of frusemide targeting a urine output.

There will be 2 groups of patients. The control group-which will receive frusemide bolus doses if required as determined by the surgeon/consultant physician. The frusemide infusion group-which will be monitored to achieve a trial specified hourly urine output target range of 1-2mls/kg/hour. In order to achieve this target the patient may need to receive a loading dose of frusemide and may also then require a frusemide infusion. The aim will be to maintain the urine output within the target range for the first 48 hours after cardiac surgery.

Eligibility

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

Criteria

Inclusion Criteria:

All patients admitted for cardiac surgery will be assessed for eligibility. Participants will be approached for inclusion, from the pre-admission clinics and wards of the Cardiothoracic surgery unit. Potential participants will be identified by the daily review of planned cardiothoracic surgery schedule.

Exclusion Criteria:

Already in established dialysis dependent chronic renal failure.
Known allergy to frusemide
Age < 18 years
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246675

Locations

Australia, Victoria
Intensive Care Unit, Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050

Sponsors and Collaborators

Melbourne Health

Investigators

Principal Investigator:

John F Cade

Royal Melbourne Hospital, Intensive Care Unit

More Information

No publications provided

Study ID Numbers:	2002.167
Study First Received:	October 27, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00246675 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Diuretics
Cardiovascular Agents
Sodium Potassium Chloride Symporter Inhibitors
Furosemide
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009