Clinical Trials Directory

Trials / Completed

CompletedNCT06614023

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

Status
Completed
Phase
Study type
Observational
Enrollment
6,448 (actual)
Sponsor
Medical University of Silesia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. 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 long-term mortality was analyzed as primary end-point. The univariable and multivariable analysis was performed using logistic regression modeling.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcoronary artery bypass graftingsurgical coronary revascularization

Timeline

Start date
2014-01-01
Primary completion
2020-09-30
Completion
2022-02-01
First posted
2024-09-26
Last updated
2024-09-26

Source: ClinicalTrials.gov record NCT06614023. Inclusion in this directory is not an endorsement.