Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors

• Conditions: Endocrine System Diseases; Cortisol Deficiency; End Stage Lung Disease; Thyroid Diseases; Diabetes Insipidus; End-stage Heart Failure
• Interventions: Procedure: Blood test

• Registration Number: NCT04351945
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

The aim of this study is to assess the impact of endocrine changes and their correction on survival and organ function in heart and lung transplant recipients. This study also features an investigation of the hormone levels and hormonal replacement therapy of the donors to study its role in the function of the transplanted hearts and lungs.

Thyroid hormones (TSH, thyroxine, tri-iodothyronine), cortisol and the antidiuretic hormone will be studied.

The former two hormone levels will be defined in the recipients just before transplantation and three days later. In the case of the donors all three hormones will be recorded at the time of the explantation. The investigators would like to record the hormonal replacement therapy in all our patients as well to see it's effect on survival and on the transplanted organ function.

After the transplantation during the hospital stays all the important hemodynamic parameters, laboratory parameters, the result of the medical imagings, the medication, the length of ICU and hospital stay and the complications were recorded.

Recipients will be followed for five years. Organ function will be assessed every three month for a year, after than every six month for further four years. Investigator would like to record the result of the cardiac echocardiography, spirometries, imaging, and complications. Our purpose is to compare these results against the endocrine disorders and the replacement therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-05-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-24
• Primary Completion: 2022-05-15
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
• written consent from the recipients

Exclusion Criteria

• lack of consent
• non-evaluable patient due to insufficient clinical information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood test	Blood test	Patients will have a blood test to define hormone levels.

Primary Outcome Measures

Name	Time	Method
Endocrine changes and their correction in heart and lung tranplant donors	one month	Number of successfully transplanted organs
The composite of in-hospital death of any cause	Patient will be followed during the hospital stay, an expected average of a month.	In-hospital death of any cause
Endocrine changes and their correction in heart and lung tranplant recipients	5 years	Five year mortality rate

Secondary Outcome Measures

Name	Time	Method
Endocrine changes and their correction in heart tranplant recipients	five years	The function of the transplanted heart
Endocrine changes and their correction in lung tranplant recipients	five years	The function of the transplanted lung
Evidence of clinically definite postoperative complications	five years	Complications occuring during five year after the transplantation

Trial Locations

Locations (1)

Heart and Vascular Center; 🇭🇺 Budapest, Pest, Hungary