Endocrine Changes in Adults Undergoing Cardiac Surgery

January 7, 2022 updated by: Andrea Szekely, Semmelweis University Heart and Vascular Center
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Heart and Vascular Center, Semmelweis University
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem Heart and Vascular Center
      • Budapest, Hungary, 1122
        • Semmeweis Egyetem Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

500 patients of a regional cardiovascular surgery centre

Description

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
The effect of psychological state of 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
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
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.
The effect of psychological state of 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
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
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

October 25, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE VSZÉK EndocrinHeart

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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