The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery Patients

Study Overview
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Brief Summary
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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 angle value measured by the bioelectrical impedance analysis.

Detailed Description
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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. Information is provided regarding protocol, aim and course of study. Only signing the consent form patients could be enrolled to the study. Study consists of: Primary assessment - information about study. Consent form. Assessment of patient according to predefined criteria. Phase angle evaluation by bioelectrical impedance. (Day prior to surgery). It is a specific cohort of patients basically governed by surgery risk and the status of patients' cells. Euroscore II value was used to evaluate the risk of surgery. Bioelectrical impedance analysis derived phase angle was used to evaluate patients' cells frailty and vitality. First phase of blood sampling - blood samples were taken for evaluation immunological status (cellular and humoral) and inflammatory response (CRB, complete blood count) at the surgery day morning prior to surgery. Surgery - evaluating the course of the surgery (see exclusion criteria). Randomization - the patients will randomly selected into intervention and control groups. The patients, physicians and investigators were separate from this process. The selection sequence was computer-generated and provided to the researchers by the statistician. Intervention - patients in the intervention group received normal daily meals plus one sachet three times a day of immune nutrients (Glutamine Plus by Fresenius Kabi) for five days after the surgery. The control group was provided with normal daily meals. The patients were excluded from the study if they failed to intake all of the prescribed immunonutrients. Second phase of blood sampling - repeated taking of blood samples for evaluation immunological status (cellular and humoral) and inflammatory response (CRB, complete blood count) at the sixth day morning after the surgery. Data collection - data is recorded (demographic data of patients, co-morbidities, instrumental parameters, phase angle values, surgery course details, immunological assesment and laboratory tests, short term and long term outcomes).

Official Title
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The Efficacy of Early Postoperative Enteral Immunonutrition on Immune Response and Outcomes in Low-Risk Cardiac Surgery Patients

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Dietary Supplement: Immunonutrients + normal daily meal
* Dietary Supplement: Normal daily meal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Normal daily meals plus one sachet three times a day of immune nutrients for five days after the surgery. 8 a.m. - normal meal plus one sachet immune nutrients 1 p.m - normal meal plus one sachet immune nutrients 6 p.m. - normal meal plus one sachet immune nutrients | Dietary Supplement: Immunonutrients + normal daily meal<br>* Glutamine Plus by Fresenius Kabi (one sachet composition: glutamine 10 g, carbohydrate 10 g, β-carotene 1.7 mg, vitamin E 83 mg, vitamin C 250 mg, zinc 3.4 mg, selenium 50 μg, and fibre 1.2 g).<br>* Other names: Normal daily meal (75-80 g protein);|
| Active Comparator: Control<br>Normal daily meals. 8 a.m. - normal meal 1 p.m. - normal meal 6 p.m. - normal meal | Dietary Supplement: Normal daily meal<br>* Normal daily meal (75-80 g protein)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ T cell | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD4+ T cells. | Six days | 
| CD8+ T cell | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD8+ T cells. | Six days | 
| CD69+ T cell | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD69+ T cells. | Six days | 
| Interleukin-1 (IL-1) | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-1. | Six days | 
| Interleukin-6 (IL-6) | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-6. | Six days | 
| Tumor necrosis factor alfa (TNFα) | Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for TNFα. | Six days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Short-term postoperative outcome. | 28 days | 
| Stroke | Short-term postoperative outcome. | 28 days | 
| ICU infectious complications | Short-term postoperative outcome. It was examined deep wound infections, ventilator associated and hospital acquired pneumonia, urinary tract infections, bloodstream infections, catheter-related bloodstream infections. | 28 days | 
| Duration of mechanical ventilation | Short-term postoperative outcome. | 28 days | 
| Retoracotomy rate | Short-term postoperative outcome. | 28 days | 
| Mortality | Long-term postoperative outcome. | 2 years | 
| Duration of hospital stay | Short-term postoperative outcome. | 28 days | 
| Rate of rehospitalization | Long-term postoperative outcome. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Immunonutrition Glutamine Bioelectrical impedance, Immunological status