Endocrine Changes in Adults Undergoing Cardiac Surgery

• Conditions: Endocrine System Diseases; Quality of Life; Cardiac Surgery; Psychology, Social

• Registration Number: NCT03736499
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Primary Completion: 2020-06-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• elective cardiac surgery

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (3)

Heart and Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Semmeweis Egyetem Heart and Vascular Center; 🇭🇺 Budapest, Hungary