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Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

NCT02675374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Hemodynamic Instability
  • Vasoplegic Syndrome

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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Cédrick ZAOUTER, Dr · University Hospital, Bordeaux

  • Antoine BENARD, Dr · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-05
Primary Completion
2017-07-18
Completion
2017-07-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675374 on ClinicalTrials.gov