Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

San Donato Group (GSD)

Status and phase: Completed; Phase 4

Conditions: Cardiac Complications; Cardiopulmonary Bypass

Treatments: Drug: Placebo; Drug: Fenoldopam mesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT00747331

FenoldopamCPB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Age < 18 years
• No written informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Fenoldopam mesilate

B

Placebo Comparator group

Treatment:

Drug: Placebo