Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery.
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ClinicalTrials.gov Identifier: NCT00246675 |
Recruitment Status :
Withdrawn
(The study has ceased recruiting as Ethics approval has lapsed and the investigator availability reduced.)
First Posted : October 30, 2005
Last Update Posted : April 27, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | October 27, 2005 | |||
First Posted Date ICMJE | October 30, 2005 | |||
Last Update Posted Date | April 27, 2015 | |||
Study Start Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Frusemide Infusion for the Prevention of Deterioration in Renal Function Post Cardiac Surgery. | |||
Official Title ICMJE | Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Renal Impairment After Cardiac Surgery | |||
Intervention ICMJE | Drug: Frusemide | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Enrollment ICMJE |
400 | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00246675 | |||
Other Study ID Numbers ICMJE | 2002.167 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Melbourne Health | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Melbourne Health | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |