Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246675
Status:
WITHDRAWN
Last Update Posted:
2015-04-27
First Post:
2005-10-27
Brief Title:
Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 receivenot 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 surgeonconsultant physician The frusemide infusion group-which will be monitored to achieve a trial specified hourly urine output target range of 1-2mlskghour 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
There will be 2 groups of patients The control group-which will receive frusemide bolus doses if required as determined by the surgeonconsultant physician The frusemide infusion group-which will be monitored to achieve a trial specified hourly urine output target range of 1-2mlskghour 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None