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

NCT ID: NCT04351945

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2022-07-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Blood test

Patients will have a blood test to define hormone levels.

Blood test

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

transplantation; explantation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role: lead

Responsible Party

Andrea Szekely

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea dr. Székely, MD PhD

Role: STUDY_DIRECTOR

Semmelweis University

Ágnes dr. Sándor, MD

Role: PRINCIPAL_INVESTIGATOR

Semmeweis University

András dr. Szabó, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

Heart and Vascular Center

Budapest, Pest County, Hungary

Countries

Hungary

Other Identifiers

VSZÉK TRANSPLANT

Identifier Type: -

Identifier Source: org_study_id