Clinical trial NCT04351945: Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Official title: A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endocrine System Diseases
Thyroid Diseases
Cortisol Deficiency
Diabetes Insipidus
End-stage Heart Failure
End Stage Lung Disease
Keywords: transplantation
endocrine
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Semmelweis University
First posted: 2020-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing heart or lung transplation and their organ donors.

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.


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

Primary outcomes:
measure: The composite of in-hospital death of any cause
timeFrame: Patient will be followed during the hospital stay, an expected average of a month.
measure: Endocrine changes and their correction in heart and lung tranplant recipients
timeFrame: 5 years
measure: Endocrine changes and their correction in heart and lung tranplant donors
timeFrame: one month
Secondary outcomes:
measure: Endocrine changes and their correction in heart tranplant recipients
timeFrame: five years
measure: Endocrine changes and their correction in lung tranplant recipients
timeFrame: five years
measure: Evidence of clinically definite postoperative complications
timeFrame: five years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center
state: Pest
Study officials:
affiliation: Semmelweis University
name: Andrea dr. Székely, MD PhD
role: STUDY_DIRECTOR
affiliation: Semmeweis University
name: Ágnes dr. Sándor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: András dr. Szabó, MD
role: PRINCIPAL_INVESTIGATOR
References: