Endocrine System DiseasesNCT03736499
Endocrine Changes in Adults Undergoing Cardiac Surgery
An observational study of Endocrine System Diseases and Cardiac Surgery, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endocrine System Diseases, Cardiac Surgery, Quality of Life
- How many people
- 500 participants
- Where
- 3 sitesHungary
- Study dates
- 1 Jul 2018to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 patients of a regional cardiovascular surgery centre
Who may be able to join
- elective cardiac surgery
Who cannot join
- lack of consent
- pregnancy
- acute surgery
- exposition with iodin-containing contrast material
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Heart and Vascular Center, Semmelweis University
Budapest, 1122
Semmelweis Egyetem Heart and Vascular Center
Budapest, 1122
Semmeweis Egyetem Heart and Vascular Center
Budapest, 1122
About this study
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.
Read the 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.
- Medical subject headings
- Endocrine System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Any cause of death in current group
Measured: 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
The effect of psychological state of the length of hospital stay
Measured: 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
The effect of psychological state of the length of hospital stay
Measured: 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
The effect of psychological state of the length of hospital stay
Measured: 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
Correlation between the preoperative quality of life state and the hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Szekely, Semmelweis University Heart and Vascular Center
- Investigators
- Andrea Székely, ass. prof, Study director, Semmelweis EgyetemÁgnes Sándor, PhD st, Principal investigator, Semmelweis EgyetemAndrás Szabó, PhD st, Principal investigator, Semmelweis Egyetem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736499
- Sponsor's protocol ID
- SE VSZÉK EndocrinHeart
- Status last verified
- Jan 2022
- First submitted
- 25 Oct 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28967725Brozaitiene 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.
PubMed 26892923Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. doi: 10.4081/monaldi.2013.5232.
PubMed 25087292Maggio 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.
PubMed 22414875Fleischer 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.
PubMed 18360264Kunst 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.
PubMed 11052436Razvi 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.
PubMed 29673469Szecsi 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.
PubMed 37540593Toth 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.
PubMed 35610144
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Changes in Adults Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03736499
- Acronym / sponsor ID
- SE VSZÉK EndocrinHeart
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients of a regional cardiovascular surgery centre
Key inclusion criteria (1 listed)
- elective cardiac surgery
Key exclusion criteria (4 listed)
- lack of consent
- pregnancy
- acute surgery
- exposition with iodin-containing contrast material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital and intensive care unit stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The correlation of the measured pre and postoperative endocrine profile and the length of intensive care unit stay
5 secondary outcomes
The composite of in-hospital death from any cause.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 28967725Aversa 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.
- Background: PubMed 26892923Brozaitiene 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.
- Background: PubMed 25087292Bianchi V, Mezzani A. Androgens and cardiac diseases. Monaldi Arch Chest Dis. 2013 Dec;80(4):161-9. doi: 10.4081/monaldi.2013.5232.
- Background: PubMed 22414875Maggio 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.
- Background: PubMed 18360264Fleischer 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.
- Background: PubMed 11052436Kunst 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.
- Results publication: PubMed 29673469Razvi 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.
- Derived from this study: PubMed 37540593Szecsi 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.
- Derived from this study: PubMed 35610144Toth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Székely, ass. prof study director
Semmelweis Egyetem
Ágnes Sándor, PhD st principal investigator
Semmelweis Egyetem
András Szabó, PhD st principal investigator
Semmelweis Egyetem
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine System Diseases and Cardiac Surgery, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital and intensive care unit stay (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736499, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022; AzTrials last refreshed its copy on 2 Nov 2026.