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

NCT ID: NCT04047095

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2021-10-01

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 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).

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Immunonutrients + normal daily meal

Intervention Type: 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).

Control

Normal daily meals. 8 a.m. - normal meal

1 p.m. - normal meal 6 p.m. - normal meal

Group Type: ACTIVE_COMPARATOR

Normal daily meal

Intervention Type: DIETARY_SUPPLEMENT

Normal daily meal (75-80 g protein)

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Normal daily meal

Normal daily meal (75-80 g protein)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Normal daily meal (75-80 g protein)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Donata Ringaitiene

PhD Vilnius University Institute of Clinical Medicine Clinic of Anaesthesiology and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jurate Sipylaite, MD, PhD

Role: STUDY_CHAIR

Vilnius University, Faculty of Medicine

Locations

Vilnius University Hospital Santaros klinikos

Vilnius, , Lithuania

Countries

Lithuania

References

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.

Reference Type: DERIVED

PMID: 32513480 (View on PubMed)

Other Identifiers

123

Identifier Type: -

Identifier Source: org_study_id