Clinical trial NCT03736499: Endocrine Changes in Adults Undergoing Cardiac Surgery
Official title: Endocrine Changes in Adults Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endocrine System Diseases
Cardiac Surgery
Quality of Life
Psychology, Social
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients of a regional cardiovascular surgery centre

Brief summary: In this prospective study the investigators want to measure the serum level changes of the thyroid hormones (thyroid-stimulating hormone, reverse triiodothyronine, serum free T4), brain natriuretic peptide (BNP), testosterone and sexual hormone binding protein (SHBG) in adults undergoing cardiac surgery and search for correlations different psychosocial factors and analyze the influence on the survival and the length of ICU/hospital stay.

Detailed description: In this study the investigators want to analyze routinely collected data of patients who underwent any kind of elective cardiac surgery in our university cardiovascular centre between 07.01.2018 and 30.06.2020. The database contains descriptive parameters, history of past illnesses, recent medication. The investigators record the type of surgery, the list of contributory physicians, the length of the surgery and the data of the anaesthesiological report. After the surgery the researchers want to record the postoperative parameters on the ICU ( infusion - fluid balance, blood transfusion, bleeding, main hemodynamic parameters, length of mechanical ventilation,main parameters of arterial blood gas analysis). Moreover th investigators want to collect psychosocial tests (Beck Depression Inventory, State Anxiety Scale, Trait Anxiety Scale and EQ-5D for the measurement of quality of life) to get more information from the postoperative condition of the patients.

Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

* lack of consent
* pregnancy
* acute surgery
* exposition with iodin-containing contrast material

Primary outcomes:
measure: Length of hospital and intensive care unit stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary outcomes:
measure: The composite of in-hospital death from any cause.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
measure: Correlation between preoperative Beck Depression Inventory and the length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
measure: Correlation between preoperative State Anxiety Scale and the length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
measure: Correlation between preoperative Trait Anxiety Scale and the length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
measure: Correlation between preoperative EQ-5D inventory and the length of total hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center, Semmelweis University
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Heart and Vascular Center
city: Budapest
country: Hungary
facility: Semmeweis Egyetem Heart and Vascular Center
Study officials:
affiliation: Semmelweis Egyetem
name: Andrea Székely, ass. prof
role: STUDY_DIRECTOR
affiliation: Semmelweis Egyetem
name: Ágnes Sándor, PhD st
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis Egyetem
name: András Szabó, PhD st
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aversa A, Fabbri A. Testicular and thyroid function as survival predictors in the elderly patient candidate to surgery. Monaldi Arch Chest Dis. 2017 Jul 18;87(2):841. doi: 10.4081/monaldi.2017.841.
citation: Brozaitiene J, Mickuviene N, Podlipskyte A, Burkauskas J, Bunevicius R. Relationship and prognostic importance of thyroid hormone and N-terminal pro-B-Type natriuretic peptide for patients after acute coronary syndromes: a longitudinal observational study. BMC Cardiovasc Disord. 2016 Feb 18;16:45. doi: 10.1186/s12872-016-0226-2.
citation: Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. doi: 10.4081/monaldi.2013.5232.
citation: Maggio M, Nicolini F, Cattabiani C, Beghi C, Gherli T, Schwartz RS, Valenti G, Ceda GP. Effects of testosterone supplementation on clinical and rehabilitative outcomes in older men undergoing on-pump CABG. Contemp Clin Trials. 2012 Jul;33(4):730-8. doi: 10.1016/j.cct.2012.02.019. Epub 2012 Mar 5.
citation: Fleischer J, McMahon DJ, Hembree W, Addesso V, Longcope C, Shane E. Serum testosterone levels after cardiac transplantation. Transplantation. 2008 Mar 27;85(6):834-9. doi: 10.1097/TP.0b013e318166ac10.
citation: Kunst G, Pfeilschifter J, Kummermehr G, Luntz S, Bauer H, Martin E, Motsch J. Assessment of sex hormone-binding globulin and osteocalcin in patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2000 Oct;14(5):546-52. doi: 10.1053/jcan.2000.9450.
citation: Razvi S, Jabbar A, Pingitore A, Danzi S, Biondi B, Klein I, Peeters R, Zaman A, Iervasi G. Thyroid Hormones and Cardiovascular Function and Diseases. J Am Coll Cardiol. 2018 Apr 24;71(16):1781-1796. doi: 10.1016/j.jacc.2018.02.045.
citation: Toth K, Szabo A, Menyhard J, Benke K, Radovits T, Polos M, Merkely B, Gal J, Szekely A. Poor Preoperative Nutritional Status, but Not Hormone Levels, Are Associated With Mortality After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3074-3083. doi: 10.1053/j.jvca.2022.04.035. Epub 2022 Apr 29.