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

Endocrine System Diseases Clinical Trial

Official title:

A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04351945
• Other study ID #: VSZÉK TRANSPLANT
• Status: Active, not recruiting
• Start date: May 20, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2022
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 1, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cortisol Deficiency
• Diabetes Insipidus
• End Stage Lung Disease
• End-stage Heart Failure
• Endocrine System Diseases
• Lung Diseases
• Thyroid Diseases

Intervention

Procedure:
• Blood test
Hormone levels will be measured just before transplantation, and three day after the transplantation. In case of the donors hormone levels will be defined during the explantation.

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center	Budapest	Pest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of in-hospital death of any cause	In-hospital death of any cause	Patient will be followed during the hospital stay, an expected average of a month.
Primary	Endocrine changes and their correction in heart and lung tranplant recipients	Five year mortality rate	5 years
Primary	Endocrine changes and their correction in heart and lung tranplant donors	Number of successfully transplanted organs	one month
Secondary	Endocrine changes and their correction in heart tranplant recipients	The function of the transplanted heart	five years
Secondary	Endocrine changes and their correction in lung tranplant recipients	The function of the transplanted lung	five years
Secondary	Evidence of clinically definite postoperative complications	Complications occuring during five year after the transplantation	five years