The role of dexchlorpheniramine (Polaramine®) to prevent hemodynamic instability after separation from cardiopulmonary bypass during cardiac surgery.

The role of dexchlorpheniramine (Polaramine®) to prevent hemodynamic instability after separation from cardiopulmonary bypass during cardiac surgery. - HIPPIE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000505-39-FR

Enrollment

Registered

2015-06-30

Start date

2015-03-19

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vasoplegic syndrome MedDRA version: 18.0 Level: LLT Classification code 10067654 Term: Vasoplegic syndrome System Organ Class: 100000004863

Interventions

Trade Name: POLARAMINE 5 mg/1 ml, solution injectable Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXCHLORPHENIRAMINE MALEATE Current Sponsor code: Dexchlorpheniramine Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men aged 18 and older Post menopausal women Patients scheduled for an aortic valve replacement with a traditional sternotomy and CBP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: - Patients with a left ventricular ejection fraction lower than 40%, - Patients with pulmonary arterial hypertension higher than 50mmHg, - Redo cardiac surgery, - Atrioventricular and intraventricular conduction disturbances - 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
Primary end point(s): vasoplegic syndrom after surgery;Timepoint(s) of evaluation of this end point: 24 hours after surgery;Main Objective: To determine the effect of dexchlorpheniramine (Polaramine®) compared to placebo (saline solution) on maintaining patient's hemodynamic stability after separation from cardiopulmonary bypass.;Secondary Objective: - Assessment of dexchlorpheniramine effects (Polaramine®) on patients presenting metabolic disease, a comorbidity known to increase the risk for vasoplegic syndrome during cardiac surgery under CBP (diabetes and/or chronic renal and/or liver insufficiency). - Comparison of the incidence of postoperative complications (renal failure, mesenteric ischemia, liver insufficiency) between the groups - Compare patients who received 10 mg of dexchlorpheniramine (Polaramine®) and those who received placebo, regarding the following data: o The length of hospital stay, o The amount of fluids delivered o The amount of catecholamine infused o Mortality at day 28 and at 6 months. - Assess patient's tolerance to Polaramine® in patients undergoing cardiac surgery requiring CBP.	—

Measure

Time frame

Primary end point(s): vasoplegic syndrom after surgery;Timepoint(s) of evaluation of this end point: 24 hours after surgery;Main Objective: To determine the effect of dexchlorpheniramine (Polaramine®) compared to placebo (saline solution) on maintaining patient's hemodynamic stability after separation from cardiopulmonary bypass.;Secondary Objective: - Assessment of dexchlorpheniramine effects (Polaramine®) on patients presenting metabolic disease, a comorbidity known to increase the risk for vasoplegic syndrome during cardiac surgery under CBP (diabetes and/or chronic renal and/or liver insufficiency). - Comparison of the incidence of postoperative complications (renal failure, mesenteric ischemia, liver insufficiency) between the groups - Compare patients who received 10 mg of dexchlorpheniramine (Polaramine®) and those who received placebo, regarding the following data: o The length of hospital stay, o The amount of fluids delivered o The amount of catecholamine infused o Mortality at day 28 and at 6 months. - Assess patient's tolerance to Polaramine® in patients undergoing cardiac surgery requiring CBP.

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Blood histamine dosage 2. Immunophenotyping of basophil polynuclear cell 3. Pulmonary artery pressure 4. Creatinemia 5. Digestive ischemia 6. Vasoplegic syndrom after surgery for the subgroup 7. Hepatic insufficiency 8. Number of days of hospitalization and mortality ;Timepoint(s) of evaluation of this end point: 1. Day 0 2. Day 0 3. Day 0 to day 2 4. Day 28 and 6 months 5. Day 28 and 6 months 6. Day 0 7. Day 28 and 6 months 8. Day 28 and 6 months	—

Measure

Time frame

Secondary end point(s): 1. Blood histamine dosage 2. Immunophenotyping of basophil polynuclear cell 3. Pulmonary artery pressure 4. Creatinemia 5. Digestive ischemia 6. Vasoplegic syndrom after surgery for the subgroup 7. Hepatic insufficiency 8. Number of days of hospitalization and mortality ;Timepoint(s) of evaluation of this end point: 1. Day 0 2. Day 0 3. Day 0 to day 2 4. Day 28 and 6 months 5. Day 28 and 6 months 6. Day 0 7. Day 28 and 6 months 8. Day 28 and 6 months

—

Countries

France

Contacts

Public ContactREC

CHU de Bordeaux

vincent.dejarnac@chu-bordeaux.fr33557821097

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026