Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation
- Conditions
- Hemodynamic InstabilityVasoplegic Syndrome
- Interventions
- Drug: Placebo injection
- Registration Number
- NCT02675374
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Men aged 18 and older
- Post menopausal women
- Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group dexchlorpheniramine (Polaramine®) injection 24 patients Control group Placebo injection 24 patients
- Primary Outcome Measures
Name Time Method Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) Day 2 The calculation of every ratio will be made by a software in the department
- Secondary Outcome Measures
Name Time Method Peaks of pressure measure in the lung artery perioperative Day 0, day 1, day 2 Duration of hospital stay Day 28 Mortality Day 28, month 6 Collection of adverse events potentially related to the treatment Day 0, day1, day 2, day 28, month 6 Blood dosage of histamine Day 0 Assesment of patients proportion presenting metabolic disease, with abnormal ratio of sympathic-parasympathetic balance (>1.2) Day 0, day 1, day 2 Immunophenotypage of basophilic polynuclears Day 0 Measure of the amount of catecholamine infused 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
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Pessac, France