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

NCT ID: NCT00246675

Last Updated: 2015-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Renal Impairment After Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Care

Patients will only receive frusemide as per the treating physicians treatment

Group Type OTHER

Frusemide

Intervention Type DRUG

Intervention

Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour

Group Type OTHER

Frusemide

Intervention Type DRUG

Interventions

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Frusemide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role lead

Principal Investigators

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John F Cade

Role: PRINCIPAL_INVESTIGATOR

Royal Melbourne Hospital, Intensive Care Unit

Locations

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Intensive Care Unit, Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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2002.167

Identifier Type: -

Identifier Source: org_study_id

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