Endocrine Changes in Adults Undergoing Cardiac Surgery

NCT ID: NCT03736499

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2022-05-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• elective cardiac surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role: lead

Responsible Party

Andrea Szekely

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Székely, ass. prof

Role: STUDY_DIRECTOR

Semmelweis Egyetem

Ágnes Sándor, PhD st

Role: PRINCIPAL_INVESTIGATOR

Semmelweis Egyetem

András Szabó, PhD st

Role: PRINCIPAL_INVESTIGATOR

Semmelweis Egyetem

Locations

Heart and Vascular Center, Semmelweis University

Budapest, , Hungary

Semmelweis Egyetem Heart and Vascular Center

Budapest, , Hungary

Semmeweis Egyetem Heart and Vascular Center

Budapest, , Hungary

Countries

Hungary

References

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Reference Type: BACKGROUND

PMID: 28967725 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 18360264 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: RESULT

PMID: 29673469 (View on PubMed)

Szecsi B, Toth K, Szabo A, Eke C, Szentgroti R, Dohan O, Benke K, Radovits T, Polos M, Merkely B, Gal J, Szekely A. Hormonal changes in the first 24 postoperative hours after cardiac surgical procedures. Physiol Int. 2023 Aug 4;110(3):251-266. doi: 10.1556/2060.2023.00219. Print 2023 Sep 5.

Reference Type: DERIVED

PMID: 37540593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35610144 (View on PubMed)

Other Identifiers

SE VSZÉK EndocrinHeart

Identifier Type: -

Identifier Source: org_study_id