- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675374
Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation (HIPPIE)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33604
- Chu de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
24 patients
|
5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
|
Placebo Comparator: Control group
24 patients
|
5 minutes before CPB, patients will receive 2 ml of normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)
Time Frame: Day 0
|
The calculation of every ratio will be made by a software in the department
|
Day 0
|
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)
Time Frame: Day 1
|
The calculation of every ratio will be made by a software in the department
|
Day 1
|
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)
Time Frame: Day 2
|
The calculation of every ratio will be made by a software in the department
|
Day 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood dosage of histamine
Time Frame: Day 0
|
Day 0
|
Immunophenotypage of basophilic polynuclears
Time Frame: Day 0
|
Day 0
|
Peaks of pressure measure in the lung artery perioperative
Time Frame: Day 0, day 1, day 2
|
Day 0, day 1, day 2
|
Assesment of the postoperative complications incidence
Time Frame: Day 28, month 6
|
Day 28, month 6
|
Measure of the amount of fluids delivered
Time Frame: Day 0, day1, day 2
|
Day 0, day1, day 2
|
Measure of the amount of catecholamine infused
Time Frame: Day 0, day 1, day 2
|
Day 0, day 1, day 2
|
Duration of hospital stay
Time Frame: Day 28
|
Day 28
|
Mortality
Time Frame: Day 28, month 6
|
Day 28, month 6
|
Collection of adverse events potentially related to the treatment
Time Frame: Day 0, day1, day 2, day 28, month 6
|
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)
Time Frame: Day 0, day 1, day 2
|
Day 0, day 1, day 2
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Antoine BENARD, Dr, University Hospital, Bordeaux
- Principal Investigator: Cédrick ZAOUTER, Dr, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2014/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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