Pharmacological Postconditioning During the Aortic Valvular Surgery

Hospices Civils de Lyon56 enrolled

Overview

Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Aortic Valvular Surgery

Interventions

cyclosporine ADRUG

a single bolus of 2.5 mg/kg, administered before aortic cross-declamping

No injectionOTHER

No cyclosporine A is administered before aortic cross-declamping.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or females, scheduled for an aortic valvular surgery; * 18 years of age or older. Exclusion Criteria: * Combined valvular and coronary surgery; * Significant coronary artery stenosis (upper than 70%); * Left ventricular dysfunction (ejection fraction \< 40%); * Emergency surgery and/or infectious endocarditis; * Known cyclosporin hypersensitivity; * History of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis; * Renal insufficiency (creatininaemia \> 150 µmol/l); * Hepatic insufficiency (prothrombin time \< 50%); * Uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm Hg; * Women of child bearing potential, who are pregnant or not under efficient contraception; * Patients treated with nicorandil, sulfonylurea or rosuvastatine; * Patients under judicial control.

Locations (1)

Hôpital Louis Pradel

Lyon, France

Outcomes

Primary Outcomes

The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.

Time frame: 72 hours

Secondary Outcomes

Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE

Time frame: 72 hours

Data from ClinicalTrials.gov

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