CARDIAC PROTECTION WITH SEVOFLURANE IN PATIENTS WITH HIGH RISK UNDERGOING HEART SURGERY. RANDOMIZED, CONTROLLED STUDY. - ND

Phase 1

• Conditions: adult patients affected by cardiac valve and heart patology undergoing elective surgery; MedDRA version: 9.1Level: LLTClassification code 10061406Term: Cardiac valve disease

• Registration Number: EUCTR2008-001752-43-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-08
• Study Completion: 2012-09-03
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

patients with aged more then 18 years; informed consent; surgery palnned for study
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

acute ongoing heart stroke ; troponin I > 1 ng/ml; previous ipersensibility to study drug; use of sulfonilurea, teofillina o allopurinolo;toracotomy;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: verification of the benefic heart protection role of the volatile anaesthetic in heart surgery defined as reduction of time of hospitalization in intensive care unit and/or mortality rate in a population of patients at high risk undergoing surgery fot valve nd coronaric patology.;Secondary Objective: release of heart troponin I, myocardic stroke rate, time of mechanical ventilation and post surgery hospitalization.;Primary end point(s): death and/or extended hospitalization in intensive care unit (hospitalization > 2 days).