Patients should be operated for cardiac surgery with cardiac bypass and in sinus rhythm, and for which the fact of the existence of impaired left ventricular function or the heaviness of the surgical procedure, a decision Hemodynamic Monitoring intraoperative and postoperative by right heart catheterization is decided. MedDRA version: 18.1 Level: PT Classification code 10061026 Term: Cardiac operation System Organ
Conditions
Interventions
Product Name: Chlorure de sodium 7.5%
Pharmaceutical Form: Solution for injection
Trade Name: RINGER LACTATE VIAFLO
Product Name: Ringer lactate
Sponsors
Centre Hospitalier Universitaire de Grenoble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age> 18 years - Patients undergoing coronary surgery and / or elective valvular - Person affiliated to the social security or receiving such a plan - Informed consent in writing signed by the patient or his legal representative. - Patients should be operated for cardiac surgery with CPB, in sinus rhythm, and for which the fact of the existence of impaired left ventricular function or the heaviness of the surgical procedure, a decision per Hemodynamic Monitoring and post operative by right heart catheterization is decided. - Patient requiring filling of infusion solution Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - The persons referred to in Articles 1121-5 to 1121-8 of the CSP: pregnant women, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person under a legal protection measure - Severe pulmonary hypertension (systolic PAP> 60 mmHg) - Absence of preoperative sinus rhythm - Emergency Surgery - Age <18 years - Renal impairment dialyzed - Severe Hypernatremia (symptomatic, symptomatic associated with sodium and water preoperative overload).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to assess if there is an improvement in right ventricular function after infusion of hypertonic saline compared with the effect of an isotonic solution to a similar volume expansion.;Secondary Objective: ;Primary end point(s): Evolution of the ejection fraction of the right ventricle measured by Swan Ganz catheterization 30 minutes and one hour after volume expansion of a hypertonic saline solution (3 ml / kg) versus Ringer lactate (10 ml / kg) . | — |
Countries
France
Contacts
Public ContactDr Michel DURAND
Centre Hospitalier Universitaire
Outcome results
None listed