Hemodynamic Instability, Vasoplegic Syndrome
Conditions
Keywords
Cardiac surgery, cardiopulmonary bypass, dexchlorpheniramine, H1 blockers, norepinephrine, histamine release
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.
Interventions
DRUGdexchlorpheniramine (Polaramine®) injection
5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
DRUGPlacebo injection
5 minutes before CPB, patients will receive 2 ml of normal saline
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) | Day 0 | The calculation of every ratio will be made by a software in the department |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Measure of the amount of catecholamine infused | 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 |
| Assesment of patients proportion presenting metabolic disease, with abnormal ratio of sympathic-parasympathetic balance (>1.2) | Day 0, day 1, day 2 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCédrick ZAOUTER, Dr
University Hospital, Bordeaux
STUDY_CHAIRAntoine BENARD, Dr
University Hospital, Bordeaux
Outcome results
None listed