Hemodynamic InstabilityPhase 3HIPPIENCT02675374
Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation
A Phase 3 study testing dexchlorpheniramine (Polaramine®) injection in people with Hemodynamic Instability and Vasoplegic Syndrome, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Vasoplegic Syndrome
- What is being tested?
- dexchlorpheniramine (Polaramine®) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2016to 18 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 and older
- Post menopausal women
- Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB
Who cannot join
- 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
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- Women of childbearing potential
- Patients at risk of glaucoma
- Patients with therapy interacting with dexchlorpheniramine (Polaramine®).
- Patients unable to provide a signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hemodynamic Instability, Vasoplegic Syndrome
- Being tested
- dexchlorpheniramine (Polaramine®) injection, Placebo injection
- Keywords
- Cardiac surgery, cardiopulmonary bypass, dexchlorpheniramine, H1 blockers, norepinephrine, histamine release
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexchlorpheniramine (Polaramine®) injectionDrug
5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
Placebo injectionDrug
5 minutes before CPB, patients will receive 2 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 24 patients Receives: Drug: dexchlorpheniramine (Polaramine®) injection |
| Control group | Placebo comparator | 24 patients Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 2
Secondary outcomes (10)
Blood dosage of histamine
Measured: Day 0
Immunophenotypage of basophilic polynuclears
Measured: Day 0
Peaks of pressure measure in the lung artery perioperative
Measured: Day 0, day 1, day 2
Assesment of the postoperative complications incidence
Measured: Day 28, month 6
Measure of the amount of fluids delivered
Measured: Day 0, day1, day 2
Measure of the amount of catecholamine infused
Measured: Day 0, day 1, day 2
Duration of hospital stay
Measured: Day 28
Mortality
Measured: Day 28, month 6
Collection of adverse events potentially related to the treatment
Measured: 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)
Measured: Day 0, day 1, day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start5 Jun 2016
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Why it stopped: stop due to medication error with the placebo
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédrick ZAOUTER, Dr, Principal investigator, University Hospital, BordeauxAntoine BENARD, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675374
- Sponsor's protocol ID
- CHUBX 2014/13
- Other IDs
- 2015-000505-39, 2015
- Acronym
- HIPPIE
- Status last verified
- May 2020
- First submitted
- 11 Jan 2016
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT02675374
- Acronym / sponsor ID
- HIPPIE / CHUBX 2014/13
- Conditions
- Hemodynamic Instability, Vasoplegic Syndrome
- Keywords
- Cardiac surgery, cardiopulmonary bypass, dexchlorpheniramine, H1 blockers, norepinephrine, histamine release
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stop due to medication error with the placebo
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jun 2016 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: dexchlorpheniramine (Polaramine®) injection24 patients |
| Control group | Placebo comparator | Drug: Placebo injection24 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men aged 18 and older
- Post menopausal women
- Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexchlorpheniramine (Polaramine®) injection5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine® | Drug | Treatment group |
| Placebo injection5 minutes before CPB, patients will receive 2 ml of normal saline | Drug | Control group |
Primary outcome
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
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
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
10 secondary outcomes
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
Results and safety
The study was stopped early (reason given: stop due to medication error with the placebo). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédrick ZAOUTER, Dr principal investigator
University Hospital, Bordeaux
Antoine BENARD, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexchlorpheniramine (Polaramine®) injection in people with Hemodynamic Instability and Vasoplegic Syndrome, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: stop due to medication error with the placebo). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.