Status:
COMPLETED
The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery Patients
Lead Sponsor:
Vilnius University
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The aim of this study is to investigate the efficacy of early postoperative enteral immunonutrition on immune response and outcomes in the low operative risk cardiac surgery population with low phase ...
Detailed Description
Study enrolls a low operative risk cardiac surgery patients who undergo elective cardiac surgery with cardiopulmonary bypass (CPB). Patient is offered to take part in a study a day prior to surgery. I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04047095
Start Date
February 1 2015
End Date
October 1 2021
Last Update
March 11 2022
Active Locations (1)
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1
Vilnius University Hospital Santaros klinikos
Vilnius, Lithuania, 08661