Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747331
• Other study ID #: FenoldopamCPB
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2008
• Last updated: April 10, 2009
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Complex, combined cardiac operation

• Predicted CPB duration > 90 minutes

Exclusion Criteria:

• Age < 18 years

• No written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Complications
• Cardiopulmonary Bypass

Intervention

Drug:
• Fenoldopam mesilate
Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation
• Placebo
Intravenous infusion (saline) Infused at the same rate (ml/h) as the experimental drug

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S.Donato	San donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak blood lactate levels during CPB		3 hours	No
Secondary	Urine output during CPB		3 hours	No
Secondary	Peak blood lactate levels during the postoperative period		48 hours after the end of the operation	No
Secondary	Peak serum creatinine level during the postoperative period		48 hours after the end of the operation	No