Cardiac Complications, Cardiopulmonary Bypass
Conditions
Keywords
Cardiopulmonary bypass, Lactic acidosis, Oxygen delivery, Acute renal failure, outcome, cardiac, surgery
Brief summary
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.
Detailed description
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.
Interventions
Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation
Intravenous infusion (saline) Infused at the same rate (ml/h) as the experimental drug
Sponsors
Study design
Eligibility
Inclusion criteria
* Complex, combined cardiac operation * Predicted CPB duration \> 90 minutes
Exclusion criteria
* Age \< 18 years * No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak blood lactate levels during CPB | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| Urine output during CPB | 3 hours |
| Peak blood lactate levels during the postoperative period | 48 hours after the end of the operation |
| Peak serum creatinine level during the postoperative period | 48 hours after the end of the operation |
Countries
Italy