A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endocrine System Diseases
- Sponsor
- Semmelweis University Heart and Vascular Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Endocrine changes and their correction in heart and lung tranplant donors
- Last Updated
- 4 years ago
Overview
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.
Investigators
Andrea Szekely
professor
Semmelweis University Heart and Vascular Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Endocrine changes and their correction in heart and lung tranplant donors
Time Frame: one month
Number of successfully transplanted organs
The composite of in-hospital death of any cause
Time Frame: 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
Time Frame: 5 years
Five year mortality rate
Secondary Outcomes
- Endocrine changes and their correction in heart tranplant recipients(five years)
- Endocrine changes and their correction in lung tranplant recipients(five years)
- Evidence of clinically definite postoperative complications(five years)