Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

NCT ID: NCT00747331

Last Updated: 2009-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Cardiac Complications; Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A

Group Type: EXPERIMENTAL

Fenoldopam mesilate

Intervention Type: DRUG

Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation

B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous infusion (saline)

Infused at the same rate (ml/h) as the experimental drug

Interventions

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

Intervention Type: DRUG

Placebo

Intravenous infusion (saline)

Infused at the same rate (ml/h) as the experimental drug

Intervention Type: DRUG

Other Intervention Names

Corlopam; Saline

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years
• No written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

IRCCS Policlinico S.Donato

Principal Investigators

Marco Ranucci, M.D.

Role: STUDY_DIRECTOR

IRCCS Policlinico S. Donato

Locations

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 15464494 (View on PubMed)

Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

Reference Type: DERIVED

PMID: 39607014 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20332738 (View on PubMed)

Other Identifiers

FenoldopamCPB

Identifier Type: -

Identifier Source: org_study_id