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

NCT04351945 | Unknown

• 1 other identifier: VSZÉK TRANSPLANT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

transplantation; endocrine

Outcome Measures

Primary Outcomes (3)

• The composite of in-hospital death of any cause

  In-hospital death of any cause

  Patient will be followed during the hospital stay, an expected average of a month.

• Endocrine changes and their correction in heart and lung tranplant recipients

  Five year mortality rate

  5 years

• Endocrine changes and their correction in heart and lung tranplant donors

  Number of successfully transplanted organs

  one month

Secondary Outcomes (3)

• 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

Study Arms (1)

Blood test

Patients will have a blood test to define hormone levels.

Procedure: Blood test

Interventions

Blood test 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.

Also known as: transplantation, explantation

Blood test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing heart or lung transplation and their organ donors.

You may qualify if:

• Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
• written consent from the recipients

You may not qualify if:

• lack of consent
• non-evaluable patient due to insufficient clinical information

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• Semmelweis University: collaborator

Study Sites (1)

Heart and Vascular Center

Budapest, Pest County, 1122, Hungary

Location

MeSH Terms

Conditions

Endocrine System Diseases; Thyroid Diseases; Diabetes Insipidus

Interventions

Hematologic Tests; Transplantation; Device Removal

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Surgical Procedures, Operative

Study Officials

• Andrea dr. Székely, MD PhD

  Semmelweis University

  STUDY DIRECTOR

• Ágnes dr. Sándor, MD

  Semmeweis University

  PRINCIPAL INVESTIGATOR

• András dr. Szabó, MD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: May 20, 2020
• Primary Completion: May 15, 2022
• Study Completion: July 1, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)