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TERMINATED
NCT02675374
PHASE3

Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2016-06-05

Completion Date

2017-07-18

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DRUG

dexchlorpheniramine (Polaramine®) injection

5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®

DRUG

Placebo injection

5 minutes before CPB, patients will receive 2 ml of normal saline

Locations (1)

CHU de Bordeaux

Pessac, France