Cortisol Deficiency, Diabetes Insipidus, Endocrine System Diseases, End-stage Heart Failure, End Stage Lung Disease, Thyroid Diseases
Conditions
Keywords
transplantation, endocrine
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.
Interventions
PROCEDUREBlood 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.
Sponsors
Semmelweis University
Semmelweis University Heart and Vascular Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Endocrine changes and their correction in heart and lung tranplant donors | one month | Number of successfully transplanted organs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hungary
Outcome results
None listed