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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Control | Active Comparator | Normal daily meals. 8 a.m. - normal meal 1 p.m. - normal meal 6 p.m. - normal meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrients + normal daily meal | Dietary Supplement | "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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Short-term postoperative outcome. | 28 days |
| Stroke | Short-term postoperative outcome. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Preoperative:
Operative:
Postoperative:
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| Name | Affiliation | Role |
|---|---|---|
| Jurate Sipylaite, MD, PhD | Vilnius University, Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University Hospital Santaros klinikos | Vilnius | 08661 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32513480 | Derived | Svetikiene M, Ringaitiene D, Vezeliene J, Isajevas V, Trybe D, Vicka V, Malickaite R, Jurgauskiene L, Norkuniene J, Serpytis M, Sipylaite J. The efficacy of early postoperative enteral immunonutrition on T-lymphocyte count: A randomised control study in low-risk cardiac surgery patients. Clin Nutr. 2021 Feb;40(2):372-379. doi: 10.1016/j.clnu.2020.05.009. Epub 2020 May 15. |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Normal daily meal | Dietary Supplement | Normal daily meal (75-80 g protein) |
|
| 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 |