Cardiopulmonary Bypass Clinical Trial
Official title:
Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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