Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.

Not Applicable

Withdrawn

• Conditions: Renal Impairment After Cardiac Surgery
• Interventions: Drug: Frusemide

• Registration Number: NCT00246675
• Lead Sponsor: Melbourne Health

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Frusemide	Patients will only receive frusemide as per the treating physicians treatment
Intervention	Frusemide	Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intensive Care Unit, Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia