Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
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.
Drug: Fenoldopam mesilate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.|
- Peak blood lactate levels during CPB [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Urine output during CPB [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
- Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ] [ Designated as safety issue: No ]
- Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after the end of the operation ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747331
|IRCCS Policlinico S.Donato|
|San donato Milanese, Milan, Italy, 20097|
|Study Director:||Marco Ranucci, M.D.||IRCCS Policlinico S. Donato|