NCT02675374

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

January 11, 2016

Last Update Submit

May 12, 2020

Conditions

Hemodynamic InstabilityVasoplegic Syndrome

Keywords

Cardiac surgerycardiopulmonary bypassdexchlorpheniramineH1 blockersnorepinephrinehistamine release

Outcome Measures

Primary Outcomes (3)

  • Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)

    The calculation of every ratio will be made by a software in the department

    Day 0

  • Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)

    The calculation of every ratio will be made by a software in the department

    Day 1

  • Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)

    The calculation of every ratio will be made by a software in the department

    Day 2

Secondary Outcomes (10)

  • Blood dosage of histamine

    Day 0

  • Immunophenotypage of basophilic polynuclears

    Day 0

  • Peaks of pressure measure in the lung artery perioperative

    Day 0, day 1, day 2

  • Assesment of the postoperative complications incidence

    Day 28, month 6

  • Measure of the amount of fluids delivered

    Day 0, day1, day 2

  • +5 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

24 patients

Drug: dexchlorpheniramine (Polaramine®) injection

Control group

PLACEBO COMPARATOR

24 patients

Drug: Placebo injection

Interventions

dexchlorpheniramine (Polaramine®) injectionDRUG

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

Treatment group
Placebo injectionDRUG

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 18 and older
  • Post menopausal women
  • Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Vasoplegia

Interventions

dexchlorpheniramineInjections

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Cédrick ZAOUTER, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 5, 2016

Study Start

June 5, 2016

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

FR(1)