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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood test<br>Patients will have a blood test to define hormone levels. | Procedure: Blood test<br>* 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.<br>* Other names: explantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Endocrine changes and their correction in heart and lung tranplant recipients | Five year mortality rate | 5 years | 
| Endocrine changes and their correction in heart and lung tranplant donors | Number of successfully transplanted organs | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine changes and their correction in heart tranplant recipients | The function of the transplanted heart | five years | 
| Endocrine changes and their correction in lung tranplant recipients | The function of the transplanted lung | five years | 
| Evidence of clinically definite postoperative complications | Complications occuring during five year after the transplantation | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplantation, endocrine