Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

July 26, 2022 updated by: MERVE SAHINGOZ, TC Erciyes University
Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. It is widely accepted that obesity increases the risk of heart disease and is thought to be a risk factor for adverse outcomes after cardiac surgery. However, recent studies show paradoxical results, wherein obese patients can experience fewer adverse events and lower mortality than patients with normal-low body mass index(BMI) . The discriminative capacity of BMI has been criticized because it cannot distinguish muscle mass from fat mass, or reflect fat distribution . Alternatively, abdominal obesity indices, such as waist circumference (WC) and waist-to-height ratio (WHtR), have been suggested to be better predictor of cardiometabolic abnormalities because they modulate the limitation of BMI. However, they were insufficient in studies.For this reason, scientists turned to find a new anthropometric formula that could better detect obesity-related mortality and morbidity and they developed 2 new methods. Body Shape İndex (ABSI) is calculated using waist circumference, BMI and height parameters. Body Roundness İndex (BRI) is calculated using waist circumference and height parameters. These new indices may reflect visceral adiposity and strongly predict cardiovascular risk, postsurgical outcomes and resource utilisation.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

240

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients over the age of 18 who have undergone open heart surgery

Description

Inclusion Criteria:

  • open heart surgery
  • voluntary patients

Exclusion Criteria:

  • emergency surgery
  • off-pump or robotic surgery
  • surgery requiring deep hypothermic circulatory arrest
  • reluctant patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: within 30 days of the procedure
Number of death at 30 days after surgery
within 30 days of the procedure
postoperative stroke
Time Frame: within 30 days of the procedure
Number of patients with postoperative stroke
within 30 days of the procedure
cardiac arrest
Time Frame: within 30 days of the procedure
number of patients with cardiac arrest
within 30 days of the procedure
new atrial fibrillation/flutter
Time Frame: within 30 days of the procedure
Number of Partients with new atrial fibrillation/flutter
within 30 days of the procedure
permanent rhythm device insertion
Time Frame: within 30 days of the procedure
Number of Patients requiring insertion of a permanent device
within 30 days of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prolonged ventilation
Time Frame: within 30 days of the procedure
number of patients experiencing prolonged postoperative pulmonary ventilation (>24 hours)
within 30 days of the procedure
sepsis /deep sternal infection
Time Frame: within 30 days of the procedure
number of patients with sepsis, deep sternal wound infection or mediastinitis
within 30 days of the procedure
pulmonary complications
Time Frame: within 30 days of the procedure
number of patients with pneumonia or pleural effusion
within 30 days of the procedure
renal failure / renal dialysis
Time Frame: within 30 days of the procedure
number of patient with acute renal failure or worsening renal function result
within 30 days of the procedure
total intensive care unit (ICU) hours
Time Frame: within 30 days of the procedure
total intensive care unit (ICU) hours
within 30 days of the procedure
intensive care unit (ICU) readmissions
Time Frame: within 30 days of the procedure
number of patients with intensive care unit readmission
within 30 days of the procedure

Collaborators and Investigators

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

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)

July 27, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

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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