Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 9:59 AM
Study NCT ID:
NCT04047095
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Early Postoperative Enteral Immunonutrition in Low-Risk Cardiac Surgery Patients
Sponsor:
Vilnius University
Organization:
Study Overview
Official Title:
The Efficacy of Early Postoperative Enteral Immunonutrition on Immune Response and Outcomes in Low-Risk Cardiac Surgery Patients
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: