/A

Phase 1

• Conditions: 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 Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-004485-28-FR
• Lead Sponsor: Centre Hospitalier Universitaire de Grenoble

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified