Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04047095
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years;
* Elective cardiac surgery with cardiopulmonary bypass:
* coronary artery bypass grafting surgery (CABG);
* aortic valve replacement;
* mitral valve replacement;
* mitral valve repair;
* tricuspid valve repair;
* combined operations (CABG and valve surgery);
* Phase angle \<5.5⁰ (phase angle was evaluated one day prior to surgery using bioelectrical impedance analysis (InbodyS10 device).
Exclusion Criteria:
Preoperative:
* previous cardiac surgery;
* left ventricle ejection fraction \<40%;
* use of preoperative intra-aortic balloon pump (IABP);
* critical preoperative state;
* pulmonary artery mean pressure \>55 mmHg;
* diagnosis of infectious endocarditis;
* pacemaker;
Operative:
* complicated intraoperative course (unplanned intervention or low cardiac output syndrome in the operating theatre: failure to wean from cardiopulmonary bypass (CPB) or intraoperative insertion of IABP or infusion of two or more inotropic medications with a cumulative dose of 0.2 mcg/kg/min);
* surgery time \>6 h;
* unplanned intervention;
Postoperative:
* disturbance of dietary rules.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04047095
Study Brief:
Protocol Section:
NCT04047095