Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

Sponsor
TC Erciyes University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05403294
Collaborator
(none)
240
3.2

Study Details

Study Description

Brief Summary

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 Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery
Anticipated Study Start Date :
Jul 27, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. mortality [within 30 days of the procedure]

    Number of death at 30 days after surgery

  2. postoperative stroke [within 30 days of the procedure]

    Number of patients with postoperative stroke

  3. cardiac arrest [within 30 days of the procedure]

    number of patients with cardiac arrest

  4. new atrial fibrillation/flutter [within 30 days of the procedure]

    Number of Partients with new atrial fibrillation/flutter

  5. permanent rhythm device insertion [within 30 days of the procedure]

    Number of Patients requiring insertion of a permanent device

Secondary Outcome Measures

  1. prolonged ventilation [within 30 days of the procedure]

    number of patients experiencing prolonged postoperative pulmonary ventilation (>24 hours)

  2. sepsis /deep sternal infection [within 30 days of the procedure]

    number of patients with sepsis, deep sternal wound infection or mediastinitis

  3. pulmonary complications [within 30 days of the procedure]

    number of patients with pneumonia or pleural effusion

  4. renal failure / renal dialysis [within 30 days of the procedure]

    number of patient with acute renal failure or worsening renal function result

  5. total intensive care unit (ICU) hours [within 30 days of the procedure]

    total intensive care unit (ICU) hours

  6. intensive care unit (ICU) readmissions [within 30 days of the procedure]

    number of patients with intensive care unit readmission

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • open heart surgery

  • voluntary patients

Exclusion Criteria:
  • emergency surgery

  • off-pump or robotic surgery

  • surgery requiring deep hypothermic circulatory arrest

  • reluctant patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MERVE SAHINGOZ, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT05403294
Other Study ID Numbers:
  • 2022/02
First Posted:
Jun 3, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022