Endocrine Changes in Adults Undergoing Cardiac Surgery

Quality of Life Clinical Trial

Official title:

Endocrine Changes in Adults Undergoing Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736499
• Other study ID #: SE VSZÉK EndocrinHeart
• Status: Active, not recruiting
• Start date: July 1, 2018
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2022
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: May 30, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• elective cardiac surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Endocrine System Diseases
• Psychology, Social
• Quality of Life

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center, Semmelweis University	Budapest
Hungary	Semmelweis Egyetem Heart and Vascular Center	Budapest
Hungary	Semmeweis Egyetem Heart and Vascular Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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. — View Citation

Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital and intensive care unit stay	The correlation of the measured pre and postoperative endocrine profile and the length of intensive care unit stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary	The composite of in-hospital death from any cause.	Any cause of death in current group	Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Secondary	Correlation between preoperative Beck Depression Inventory and the length of hospital stay	The effect of psychological state of the length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Secondary	Correlation between preoperative State Anxiety Scale and the length of hospital stay	The effect of psychological state of the length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Secondary	Correlation between preoperative Trait Anxiety Scale and the length of hospital stay	The effect of psychological state of the length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Secondary	Correlation between preoperative EQ-5D inventory and the length of total hospital stay	Correlation between the preoperative quality of life state and the hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.