Who is sponsoring NCT00747331?

NCT00747331 is sponsored by IRCCS Policlinico S. Donato.

What condition does NCT00747331 study?

NCT00747331 studies Cardiac Complications, Cardiopulmonary Bypass.

What drugs are being tested in NCT00747331?

Interventions: Fenoldopam mesilate, Placebo.

What is the status of NCT00747331?

NCT00747331 is currently COMPLETED.

Last reviewed 2009-04-10 · How we verify

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

NCT00747331 Phase 4 COMPLETED

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.

Details

Lead sponsor	IRCCS Policlinico S. Donato
Phase	Phase 4
Status	COMPLETED
Enrolment	80
Start date	2008-09
Completion	2009-04

Conditions

Cardiac Complications
Cardiopulmonary Bypass

Interventions

Fenoldopam mesilate
Placebo

Primary outcomes

Peak blood lactate levels during CPB — 3 hours

Countries

Italy