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

• Sponsor: Melbourne Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00246675
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment After Cardiac Surgery	Drug: Frusemide	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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. 1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay. []

2. 2. Incidence of renal failure requiring any form of renal replacement therapy. []

3. 3. Duration of post-operative hospital and ICU stay. []

4. 4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00246675
• Other Study ID Numbers: 2002.167
• First Posted: Oct 30, 2005
• Last Update Posted: Apr 27, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Renal Insufficiency; Furosemide

Study Results

No Results Posted as of Apr 27, 2015