MedTrace Logo

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

NCT04351945 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-01-24

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Semmelweis University

    collaborator OTHER

  • Semmelweis University Heart and Vascular Center

    lead OTHER

Principal Investigators

  • Andrea dr. Székely, MD PhD · Semmelweis University

  • Ágnes dr. Sándor, MD · Semmeweis University

  • András dr. Szabó, MD · Semmelweis University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2022-05-15
Completion
2022-07-01

Countries

  • Hungary

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351945 on ClinicalTrials.gov