- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06614023
Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting
Impact of Body Mass Index on Mortality in Patients Undergoing Coronary Artery Bypass Grafting: a Retrospective Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
All consecutive patients aged above eighteen who underwent isolated CABG were enrolled. Patients operated on- and off-pump were included. We reviewed elective, urgent, emergency and salvage surgeries. Patients with any additional concomitant surgical procedures were excluded.
Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI <20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI >40 kg/m2).
The primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.
Summary statistics were calculated. Continuous data are described as the median, with the interquartile range in parentheses, while categorical data are shown as numbers with percentages. Differences between groups for normally distributed, continuous variables were determined using the one-way analysis of variance with Holm-Sidak post-hoc test. The Kruskal Wallis test was used for the analysis of non-normally distributed continuous variables with Dunn's test for post hoc comparison. The chi-squared test was used for the analysis of categorical variables. Bonferoni's correction was used for post-hoc analysis. The univariable analysis was performed using logistic regression. For multivariable analysis a logistic regression model was performed, with mortality or wound infection as the dependent variable, and all other characteristics summarized in the table 1 as independent variables. The backward conditional selection was used for modeling with variables with score statistics <0.1 included in the model. Significance was assessed at p<0.05. Multiple imputation was not used to adjust for missing data. The number of valid entries for each variable and alterations in the sample size for specific analyses are described.
Analyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing isolated CABG
Exclusion Criteria:
any concomitant additional surgical procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
underweight
BMI <20.0 kg/m2
|
surgical coronary revascularization
|
|
normal weight
BMI 20.0-24.9 kg/m2
|
surgical coronary revascularization
|
|
overweight
BMI 25-29.9 kg/m2
|
surgical coronary revascularization
|
|
obesity class I
BMI 30-34.9 kg/m2
|
surgical coronary revascularization
|
|
obesity class II
BMI 35-39.9 kg/m2
|
surgical coronary revascularization
|
|
obesity class III
BMI >40 kg/m2
|
surgical coronary revascularization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
long-term mortality
Time Frame: 2014-2022
|
2014-2022
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
sternal wound infection rate
Time Frame: 2014-2022
|
2014-2022
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNW-1-065/N/3/K
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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