Clinical trial NCT03967639: Seasonal Trends of Respiratory Morbidity in Diabetic Patients
Official title: Retrospective Analysis of Seasonal Trends of Respiratory Morbidity in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Respiratory Complication
Perioperative/Postoperative Complications
Keywords: cardiac surgical procedures
respiratory mechanics
seasonal variation
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Hungarian Basic Research Council
name: GINOP
First posted: 2019-05-30
Enrollment: 9838
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged

Brief summary: Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics.

Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.

Detailed description: Our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged.

Electronic and paper documentation will be examined and anonymously analysed for the following information:

1. date of cardiac surgery,
2. type of cardiac surgery procedure,
3. demographic data (age, height, weight),
4. presence of T2DM (previous diagnosis, fasting plasma glucose level, glycated haemoglobin \[HbA1C\]),
5. presence of respiratory co-morbidities (e.g. asthma, COPD, etc.),
6. presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis)

6. respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery

Time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. Analysis of variance (ANOVA) will be carried out to explore global differences between diabetic and control patients.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018

Exclusion Criteria:

* patients older than 85 years
* patients younger than 18 years

Primary outcomes:
measure: Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery
timeFrame: Retrospective data analysis (2006-2018)
measure: Anthropometric data of patients undergoing cardiac surgery
timeFrame: Retrospective data analysis (2006-2018)
measure: Comorbidities of diabetic patients undergoing cardiac surgery
timeFrame: Retrospective data analysis (2006-2018)
measure: Smoking habits of patients undergoing cardiac surgery
timeFrame: Retrospective data analysis (2006-2018)
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged
state: Csongrad Megye
Study officials:
affiliation: Szeged University
name: Barna Babik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petak F, Kovacs BN, Agocs S, Virag K, Nyari T, Molnar A, Sudy R, Lengyel C, Babik B. Seasonal changes in proportion of cardiac surgeries associated with diabetes, smoking and elderly age. PLoS One. 2022 Sep 22;17(9):e0274105. doi: 10.1371/journal.pone.0274105. eCollection 2022.