Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.

Conditions
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Cardiac Complications, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Fenoldopam mesilate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complex, combined cardiac operation Predicted CPB duration > 90 minutes Exclusion Criteria: Age < 18 years No written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Fenoldopam mesilate<br>* Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation<br>* Other names: Corlopam;|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Intravenous infusion (saline) Infused at the same rate (ml/h) as the experimental drug<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak blood lactate levels during CPB |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary bypass, Lactic acidosis, Oxygen delivery, Acute renal failure, outcome, cardiac, surgery