Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

Hemodynamic Instability Clinical Trial

— HIPPIE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675374
• Other study ID #: CHUBX 2014/13
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Vasoplegia
• Vasoplegic Syndrome

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