Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

• Status: Completed
• Trial end date: 2017-07-18
• Target enrollment: 0
• Participant gender: All

Summary

This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Chlorpheniramine; Dexchlorpheniramine

Criteria

Inclusion Criteria:

• Men aged 18 and older

• Post menopausal women

• Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB

Exclusion Criteria:

• Patients with a left ventricular ejection fraction lower than 40%

• Patients with pulmonary arterial hypertension higher than 50mm of Hg,

• Redo cardiac surgery,

• Atrioventricular and intraventricular conduction disturbances

• Epilepsy or convulsions

• Atopic disease

• Women of childbearing potential

• Patients at risk of glaucoma

• Patients with therapy interacting with dexchlorpheniramine (Polaramine®).

• Patients unable to provide a signed informed consent