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

Frail Elderly Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05118165
• Other study ID #: SAI
• Secondary ID: SUT_SAI
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: July 11, 2023

Study information

• Verified date: November 2021
• Source: Lithuanian University of Health Sciences
• Contact: Ingrida Drigotiene, m.d.
• Phone: +37065222724
• Email: ingrida.drigotiene[@]lsmu.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: July 11, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Kwashiorkor
• Malnutrition
• Malnutrition; Protein

Intervention

Dietary Supplement:
• Dietary supplement with protein
Will be included protein supplements in the preoperative diet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative outcomes	The rate of postoperative complications	up to 2 weeks