Cardiac SurgeryNCT04047095
The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery Patients
A study testing Immunonutrients + normal daily meal and Normal daily meal in people with Cardiac Surgery, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Immunonutrients + normal daily meal and Normal daily meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Feb 2015to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Elective cardiac surgery with cardiopulmonary bypass:
- coronary artery bypass grafting surgery (CABG);
- aortic valve replacement;
- mitral valve replacement;
- mitral valve repair;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Vilnius University Hospital Santaros klinikos
Vilnius, 08661
About this study
Official title: 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.
Read the 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
- Being tested
- Immunonutrients + normal daily meal, Normal daily meal
- Keywords
- Cardiac surgery, Immunonutrition Glutamine Bioelectrical impedance, Immunological status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunonutrients + normal daily mealDietary supplement
Also called Normal daily meal (75-80 g protein)
"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 mealDietary supplement
Normal daily meal (75-80 g protein)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Normal daily meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ T cell
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD4+ T cells.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six days
Secondary outcomes (8)
Acute kidney injury
Short-term postoperative outcome.
Measured: 28 days
Stroke
Short-term postoperative outcome.
Measured: 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.
Measured: 28 days
Duration of mechanical ventilation
Short-term postoperative outcome.
Measured: 28 days
Retoracotomy rate
Short-term postoperative outcome.
Measured: 28 days
Mortality
Long-term postoperative outcome.
Measured: 2 years
Duration of hospital stay
Short-term postoperative outcome.
Measured: 28 days
Rate of rehospitalization
Long-term postoperative outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Feb 2015
- Primary completion1 Sep 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donata Ringaitiene, Vilnius University
- Investigators
- Jurate Sipylaite, MD, PhD, Study chair, Vilnius University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047095
- Sponsor's protocol ID
- 123
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2019
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32513480
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Early Postoperative Enteral Immunonutrition on Immune Response and Outcomes in Low-Risk Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT04047095
- Acronym / sponsor ID
- 123
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Immunonutrition Glutamine Bioelectrical impedance, Immunological status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Immunonutrients + normal daily mealNormal 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 | Dietary Supplement: Normal daily mealNormal daily meals. 8 a.m. - normal meal 1 p.m. - normal meal 6 p.m. - normal meal |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years;
- Elective cardiac surgery with cardiopulmonary bypass:
- coronary artery bypass grafting surgery (CABG);
- aortic valve replacement;
- mitral valve replacement;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunonutrients + normal daily mealAlso: Normal daily meal (75-80 g protein)"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). | Dietary supplement | Intervention |
| Normal daily mealNormal daily meal (75-80 g protein) | Dietary supplement | Control |
Primary outcome
CD4+ T cell
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD4+ T cells.
CD8+ T cell
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD8+ T cells.
CD69+ T cell
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for CD69+ T cells.
Interleukin-1 (IL-1)
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-1.
Interleukin-6 (IL-6)
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for IL-6.
Tumor necrosis factor alfa (TNFα)
Time frame: Six days
Blood samples were collected twice on the surgery and on the sixth postoperative day by sampling blood for TNFα.
8 secondary outcomes
Acute kidney injury
Time frame: 28 days
Stroke
Time frame: 28 days
ICU infectious complications
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
Retoracotomy rate
Time frame: 28 days
Mortality
Time frame: 2 years
Duration of hospital stay
Time frame: 28 days
Rate of rehospitalization
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 32513480Svetikiene 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurate Sipylaite, MD, PhD study chair
Vilnius University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrients + normal daily meal and Normal daily meal in people with Cardiac Surgery, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ T cell (time frame: Six days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.