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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
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    September 14, 2021
    Last Updated
    November 8, 2021
    Sponsor
    Lithuanian University of Health Sciences
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    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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