Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Phase 4

Completed

• Conditions: Cardiac Complications; Cardiopulmonary Bypass
• Interventions: Drug: Fenoldopam mesilate; Drug: Placebo

• Registration Number: NCT00747331
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-10
• Last Update Posted: 2009-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Complex, combined cardiac operation
• Predicted CPB duration > 90 minutes

Exclusion Criteria

• Age < 18 years
• No written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Fenoldopam mesilate	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Peak blood lactate levels during CPB	3 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Policlinico S.Donato; 🇮🇹 San donato Milanese, Milan, Italy