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Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty

Primary Purpose

Malnutrition; Protein, Frail Elderly Syndrome

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dietary supplement with protein

About this trial

This is an interventional prevention trial for Malnutrition; Protein focused on measuring preoperative malnutrition, frailty, cardiac surgery

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 65 years of age and older.
Patients for whom cardiac surgery will be performed on a scheduled basis.
Patients able to move without the help of others except for an aid: a stick, a walker.
Patients who speak and understand Lithuanian perfectly.
Patients who have read the informed consent form and confirmed their consent to participate in the study in writing.

Exclusion Criteria:

Patiens younger than 65 years.
No written consent of a person to participate in a biomedical research has been obtained;
Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks.
Patients with amputated lower extremities.
Patients with hepatic insufficiency, one or more of viral hepatitis.
It is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.)
Allergy to B vitamins.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

Outcomes

Primary Outcome Measures

Postoperative outcomes

The rate of postoperative complications

Secondary Outcome Measures

Full Information

NCT ID

NCT05118165

First Posted

September 14, 2021

Last Updated

November 8, 2021

Sponsor

Lithuanian University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05118165

Brief Title

Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty

Official Title

Influence of Optimization of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 12, 2021 (Anticipated)

Primary Completion Date

January 30, 2023 (Anticipated)

Study Completion Date

July 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty. Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery . Research methods: Edmonton Crispness Scale, a Mini Nutritional Assessment (MNA-SF) test will be used to select subjects. Body composition will be examined by bioelectrical impedance analysis (BIA) to determine the degree of phase angle. Changes in laboratory blood tests will be recorded and evaluated The subjects randomly will be divided into control and study groups. The diet of the patients in the study group will be optimised by protein supplements before elective heart surgery. The benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition; Protein, Frail Elderly Syndrome

Keywords

preoperative malnutrition, frailty, cardiac surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Title

intervention group

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary supplement with protein

Intervention Description

Will be included protein supplements in the preoperative diet.

Primary Outcome Measure Information:

Title

Postoperative outcomes

Description

The rate of postoperative complications

Time Frame

up to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 65 years of age and older. Patients for whom cardiac surgery will be performed on a scheduled basis. Patients able to move without the help of others except for an aid: a stick, a walker. Patients who speak and understand Lithuanian perfectly. Patients who have read the informed consent form and confirmed their consent to participate in the study in writing. Exclusion Criteria: Patiens younger than 65 years. No written consent of a person to participate in a biomedical research has been obtained; Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks. Patients with amputated lower extremities. Patients with hepatic insufficiency, one or more of viral hepatitis. It is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.) Allergy to B vitamins.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ingrida Drigotienė, m.d.

Phone

+37065222724

ingrida.drigotiene@lsmu.lt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty

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