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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001752-43-IT

Enrollment

200

Registered

2008-05-08

Start date

2008-07-17

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

adult patients affected by cardiac valve and heart patology undergoing elective surgery MedDRA version: 9.1 Level: LLT Classification code 10061406 Term: Cardiac valve disease

Interventions

Trade Name: SEVORANE Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: Sevoflurane Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 250- T

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Italy

Outcome results

None listed

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