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

NCT05118165 | Unknown

• 2 other identifiers: SAISUT_SAI
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition; Protein; Frail Elderly Syndrome

Keywords

preoperative malnutrition; frailty; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative outcomes

  The rate of postoperative complications

  up to 2 weeks

Study Arms (2)

control group

NO INTERVENTION

intervention group

EXPERIMENTAL

Dietary Supplement: Dietary supplement with protein

Interventions

Dietary supplement with protein DIETARY_SUPPLEMENT

Will be included protein supplements in the preoperative diet.

intervention group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

MeSH Terms

Conditions

Kwashiorkor; Frailty

Interventions

Dietary Supplements; Proteins

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ingrida Drigotienė, m.d.

CONTACT

+37065222724; ingrida.drigotiene@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 11, 2021
• Study Start: November 12, 2021
• Primary Completion: January 30, 2023
• Study Completion: July 11, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share