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Endocrine Changes in Adults Undergoing Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736499
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Andrea Szekely, Semmelweis University Heart and Vascular Center

Study Description
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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.

Condition or disease
Endocrine System Diseases Cardiac Surgery Quality of Life Psychology, Social

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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endocrine Changes in Adults Undergoing Cardiac Surgery
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]
    Any cause of death in current group

  2. 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. ]
    The effect of psychological state of the length of hospital stay

  3. 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. ]
    The effect of psychological state of the length of hospital stay

  4. 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. ]
    The effect of psychological state of the length of hospital stay

  5. 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. ]
    Correlation between the preoperative quality of life state and the hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500 patients of a regional cardiovascular surgery centre
Criteria

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

  • lack of consent
  • pregnancy
  • acute surgery
  • exposition with iodin-containing contrast material
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736499


Locations
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Hungary
Heart and Vascular Center, Semmelweis University
Budapest, Hungary, 1122
Semmelweis Egyetem Heart and Vascular Center
Budapest, Hungary, 1122
Semmeweis Egyetem Heart and Vascular Center
Budapest, Hungary, 1122
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
Investigators
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Study Director: Andrea Székely, ass. prof Semmelweis Egyetem
Principal Investigator: Ágnes Sándor, PhD st Semmelweis Egyetem
Principal Investigator: András Szabó, PhD st Semmelweis Egyetem
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Andrea Szekely, Associate Professor, Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03736499    
Other Study ID Numbers: SE VSZÉK EndocrinHeart
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endocrine System Diseases