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

NCT04047095 | Completed

• 1 other identifier: 123
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

Cardiac surgery; Immunonutrition Glutamine Bioelectrical impedance; Immunological status

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Acute kidney injury

  28 days

• Stroke

  28 days

• ICU infectious complications

  28 days

• Duration of mechanical ventilation

  28 days

• Retoracotomy rate

  28 days

Study Arms (2)

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

Dietary Supplement: Immunonutrients + normal daily meal

Control

ACTIVE COMPARATOR

Normal daily meals. 8 a.m. - normal meal 1 p.m. - normal meal 6 p.m. - normal meal

Dietary Supplement: Normal daily meal

Interventions

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).

Also known as: Normal daily meal (75-80 g protein)

Intervention

Normal daily meal DIETARY_SUPPLEMENT

Normal daily meal (75-80 g protein)

Control

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros klinikos

Vilnius, 08661, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 32513480 DERIVED

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Jurate Sipylaite, MD, PhD

  Vilnius University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Vilnius University Institute of Clinical Medicine Clinic of Anaesthesiology and Intensive Care

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 6, 2019
• Study Start: February 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)