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

November 8, 2021 updated by: Ingrida Drigotiene, Lithuanian University of Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: intervention group
Dietary supplement: Dietary supplement with protein
Will be included protein supplements in the preoperative diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative outcomes
Time Frame: up to 2 weeks
The rate of postoperative complications
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 12, 2021

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

July 11, 2023

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAI
  • SUT_SAI (Other Identifier: LithuanianUHS Kaunas Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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