Comparison of the protective effect of two cardioplegic solutions Custodiol versus St Thomas on the cardiac metabolism assessed by microdialysis in coronary surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014690-41-FR

Enrollment

Registered

2009-08-06

Start date

2009-10-09

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Coronary surgery MedDRA version: 12.0 Level: LLT Classification code 10011077 Term: Coronary artery bypass MedDRA version: 12.0 Level: LLT Classification code 10011090 Term: Coronary artery surgery MedDRA version: 12.0 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft MedDRA version: 12.0 Level: LLT Classification code 10011098 Term: Coronary bypass MedDRA version: 12.0 Level: LLT Classification code 10054366 Term: Coronary revascularization

Interventions

Trade Name: CUSTODIOL Pharmaceutical Form: Solution for organ preservation Product Name: Solution cardioplégique SLF 103 Pharmaceutical Form: Solution for organ preservation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - aged over 18 years - referred for Cardiovascular Surgery indicating coronary revascularization surgery - consent form signed - social security regimen affiliated 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: - Patients with an indication of beating-heart surgery - Emergency surgery and patients with myocardial infarction less than a week before the surgery - Surgery iterative

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the performance of myocardial protection by cardioplégic solution Custodiol versus St Thomas per procedure by measuring the changes of anoxic myocardial interstitial space by the technique of cardiac microdialysis;Secondary Objective: To compare the effects of myocardial protection of these two cardioplégic solutions (Custodiol and St Thomas) during the first 24 postoperative hours;Primary end point(s): Mean concentrations of interstitial lactate (peak lactate and ratio lactate / pyruvate) observed between the intervention began and when the unclamping in both groups of patients (St Thomas group versus Custodiol group)	—

Measure

Time frame

Main Objective: To compare the performance of myocardial protection by cardioplégic solution Custodiol versus St Thomas per procedure by measuring the changes of anoxic myocardial interstitial space by the technique of cardiac microdialysis;Secondary Objective: To compare the effects of myocardial protection of these two cardioplégic solutions (Custodiol and St Thomas) during the first 24 postoperative hours;Primary end point(s): Mean concentrations of interstitial lactate (peak lactate and ratio lactate / pyruvate) observed between the intervention began and when the unclamping in both groups of patients (St Thomas group versus Custodiol group)

—

Countries

France

Outcome results

None listed

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