- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403294
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
Status
Not yet recruiting
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/02
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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