A Phase 3 interventional study of dexchlorpheniramine (Polaramine®) injection and Placebo injection in Hemodynamic Instability and Vasoplegic Syndrome, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Prevention
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.
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 18 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24 patients
Drug: dexchlorpheniramine (Polaramine®) injection
24 patients
Drug: Placebo injection
5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
5 minutes before CPB, patients will receive 2 ml of normal saline
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
Time frame: Day 0
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
Time frame: Day 1
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
Time frame: Day 2
Blood dosage of histamine
Time frame: Day 0
Immunophenotypage of basophilic polynuclears
Time frame: Day 0
Peaks of pressure measure in the lung artery perioperative
Time frame: Day 0, day 1, day 2
Assesment of the postoperative complications incidence
Time frame: Day 28, month 6
Measure of the amount of fluids delivered
Time frame: Day 0, day1, day 2
Measure of the amount of catecholamine infused
Time frame: Day 0, day 1, day 2
Duration of hospital stay
Time frame: Day 28
Mortality
Time frame: Day 28, month 6
Collection of adverse events potentially related to the treatment
Time frame: 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
Ran from Jun 2016 to primary completion in Jul 2017, 13 months.
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This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexchlorpheniramine
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