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

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

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Dietary supplement: Immunonutrients + normal daily meal; Dietary supplement: Normal daily meal

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).

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; "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).; Other Names: Normal daily meal (75-80 g protein)
Active Comparator: Control; Normal daily meals. 8 a.m. - normal meal 1 p.m. - normal meal 6 p.m. - normal meal	Dietary supplement: Normal daily meal; Normal daily meal (75-80 g protein)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: August 4, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac surgery; Immunonutrition Glutamine Bioelectrical impedance; Immunological status
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No