NCT03736499|Unknown
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Sponsor study identifier
observational
500
1 country
3
Study Start
July 1, 2018
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2018
Actual (reported)October 25, 2018
Actual (reported)November 9, 2018
Actual (reported)June 30, 2020
Actual (reported)May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
500 patients of a regional cardiovascular surgery centre
Heart and Vascular Center, Semmelweis University
Budapest, 1122, Hungary
Semmelweis Egyetem Heart and Vascular Center
Budapest, 1122, Hungary
Semmeweis Egyetem Heart and Vascular Center
Budapest, 1122, Hungary
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.
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.
Andrea Székely, ass. prof
Semmelweis Egyetem
Ágnes Sándor, PhD st
Semmelweis Egyetem
András Szabó, PhD st
Semmelweis Egyetem
First Submitted
October 25, 2018
First Posted
November 9, 2018
Study Start
July 1, 2018
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study of Endocrine-Related Conditions and Physiology
Contact the study team to confirm eligibility.
Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. doi: 10.4081/monaldi.2013.5232.
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.
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.
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.
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.
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.
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.
Study Completion
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 11, 2022
Record last verified: 2022-01
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