The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery Patients
Condition: Cardiac Surgery
Study type: Interventional

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 angle value measured by the bioelectrical impedance analysis.
    

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. 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).
    

Intervention name(s): Immunonutrients + normal daily meal; Normal daily meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): "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).; Normal daily meal (75-80 g protein)
Other intervention name(s): Normal daily meal (75-80 g protein)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cardiac surgery; Immunonutrition Glutamine Bioelectrical impedance; Immunological status