Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT00747331|
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : April 13, 2009
Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases.
Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1 mcg/kg/min.
The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Complications Cardiopulmonary Bypass||Drug: Fenoldopam mesilate Drug: Placebo||Phase 4|
Randomized placebo-controlled double blinded study. Patients undergoing complex cardiac operations will be randomly allocated to the study or the control group.
All the patients will receive the standard of care of our Institution. Adequacy of CPB perfusion will be assessed using oxygen delivery calculation, lactate production, SvO2.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Drug: Fenoldopam mesilate
Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation
Other Name: Corlopam
|Placebo Comparator: B||
Intravenous infusion (saline)
Infused at the same rate (ml/h) as the experimental drug
Other Name: Saline
- Peak blood lactate levels during CPB [ Time Frame: 3 hours ]
- Urine output during CPB [ Time Frame: 3 hours ]
- Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
- Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747331
|IRCCS Policlinico S.Donato|
|San donato Milanese, Milan, Italy, 20097|
|Study Director:||Marco Ranucci, M.D.||IRCCS Policlinico S. Donato|