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
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition; Protein focused on measuring preoperative malnutrition, frailty, cardiac surgery
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Email
ingrida.drigotiene@lsmu.lt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
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