Clinical trial NCT00747331: Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
Official title: Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Complications
Cardiopulmonary Bypass
Keywords: Cardiopulmonary bypass
Lactic acidosis
Oxygen delivery
Acute renal failure
outcome
cardiac
surgery
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2008-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Complex, combined cardiac operation
* Predicted CPB duration \> 90 minutes

Exclusion Criteria:

* Age \< 18 years
* No written informed consent

Primary outcomes:
measure: Peak blood lactate levels during CPB
timeFrame: 3 hours
Secondary outcomes:
measure: Urine output during CPB
timeFrame: 3 hours
measure: Peak blood lactate levels during the postoperative period
timeFrame: 48 hours after the end of the operation
measure: Peak serum creatinine level during the postoperative period
timeFrame: 48 hours after the end of the operation
Other outcomes:
Locations:
city: San donato Milanese
country: Italy
facility: IRCCS Policlinico S.Donato
state: Milan
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Marco Ranucci, M.D.
role: STUDY_DIRECTOR
References:
citation: Ranucci M, Soro G, Barzaghi N, Locatelli A, Giordano G, Vavassori A, Manzato A, Melchiorri C, Bove T, Juliano G, Uslenghi MF. Fenoldopam prophylaxis of postoperative acute renal failure in high-risk cardiac surgery patients. Ann Thorac Surg. 2004 Oct;78(4):1332-7; discussion 1337-8. doi: 10.1016/j.athoracsur.2004.02.065.
citation: Ranucci M, De Benedetti D, Bianchini C, Castelvecchio S, Ballotta A, Frigiola A, Menicanti L. Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study. Minerva Anestesiol. 2010 Apr;76(4):249-59.