Endocrine Changes in Adults Undergoing Cardiac Surgery

Sponsor
Semmelweis University Heart and Vascular Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03736499
Collaborator
(none)
500
3
46.9
166.7
3.5

Study Details

Study Description

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 Intervention/Treatment Phase

    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

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

    Outcome Measures

    Primary Outcome Measures

    1. Length of hospital and intensive care unit stay [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. [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • elective cardiac surgery
    Exclusion Criteria:
    • lack of consent

    • pregnancy

    • acute surgery

    • exposition with iodin-containing contrast material

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart and Vascular Center, Semmelweis University Budapest Hungary 1122
    2 Semmelweis Egyetem Heart and Vascular Center Budapest Hungary 1122
    3 Semmeweis Egyetem Heart and Vascular Center Budapest Hungary 1122

    Sponsors and Collaborators

    • Semmelweis University Heart and Vascular Center

    Investigators

    • Study Director: Andrea Székely, ass. prof, Semmelweis Egyetem
    • Principal Investigator: Ágnes Sándor, PhD st, Semmelweis Egyetem
    • Principal Investigator: András Szabó, PhD st, Semmelweis Egyetem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Nov 9, 2018
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022