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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02675374
Other study ID # CHUBX 2014/13
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 5, 2016
Est. completion date July 18, 2017

Study information

Verified date May 2020
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Vasoplegic syndrome is recognized as a common complication after CPB. Its incidence ranges from 5% to 25% after cardiac surgery requiring CPB. Such syndrome is related to an inflammatory reaction, which is attributed to the CPB. This syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs.

Investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. Tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. According to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances.

The hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. This study aims to determine the effect of an antihistamine (dexchlorpheniramine (Polaramine®)) administered intravenously before CPB, on the vasoplegic syndrome incidence after separation from CPB.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date July 18, 2017
Est. primary completion date July 18, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
dexchlorpheniramine (Polaramine®) injection
5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
Placebo injection
5 minutes before CPB, patients will receive 2 ml of normal saline

Locations

Country Name City State
France CHU de Bordeaux Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Blood dosage of histamine Day 0
Secondary Immunophenotypage of basophilic polynuclears Day 0
Secondary Peaks of pressure measure in the lung artery perioperative Day 0, day 1, day 2
Secondary Assesment of the postoperative complications incidence Day 28, month 6
Secondary Measure of the amount of fluids delivered Day 0, day1, day 2
Secondary Measure of the amount of catecholamine infused Day 0, day 1, day 2
Secondary Duration of hospital stay Day 28
Secondary Mortality Day 28, month 6
Secondary Collection of adverse events potentially related to the treatment Day 0, day1, day 2, day 28, month 6
Secondary Assesment of patients proportion presenting metabolic disease, with abnormal ratio of sympathic-parasympathetic balance (>1.2) Day 0, day 1, day 2
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