Endocrine Changes in Adults Undergoing Cardiac Surgery

NCT03736499 | Unknown

• 1 other identifier: SE VSZÉK EndocrinHeart
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The composite of in-hospital death from any cause.

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

• Correlation between preoperative Beck Depression Inventory and the length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

• Correlation between preoperative State Anxiety Scale and the length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

• Correlation between preoperative Trait Anxiety Scale and the length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

• Correlation between preoperative EQ-5D inventory and the length of total hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 patients of a regional cardiovascular surgery centre

You may qualify if:

• elective cardiac surgery

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (3)

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

Location

Semmelweis Egyetem Heart and Vascular Center

Budapest, 1122, Hungary

Location

Semmeweis Egyetem Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (9)

• 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.

  PMID: 28967725 BACKGROUND

• 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.

  PMID: 26892923 BACKGROUND

• Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. doi: 10.4081/monaldi.2013.5232.

  PMID: 25087292 BACKGROUND

• 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.

  PMID: 22414875 BACKGROUND

• 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.

  PMID: 18360264 BACKGROUND

• 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.

  PMID: 11052436 BACKGROUND

• 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.

  PMID: 29673469 RESULT

• 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.

  PMID: 37540593 DERIVED

• 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.

  PMID: 35610144 DERIVED

MeSH Terms

Conditions

Endocrine System Diseases

Study Officials

• Andrea Székely, ass. prof

  Semmelweis Egyetem

  STUDY DIRECTOR

• Ágnes Sándor, PhD st

  Semmelweis Egyetem

  PRINCIPAL INVESTIGATOR

• András Szabó, PhD st

  Semmelweis Egyetem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 9, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: May 30, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3)