Hemodynamic Instability Clinical Trial
— HIPPIEVerified date | May 2020 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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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