Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Kidney Diseases, Kidney Transplant, Hyperthyroidism. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
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Официальное название
Hyperthyroidism in the Immediate Post-kidney Transplantation Period: a Potential Predictive of Worse Outcome of Renal Graft
Обзор
The objectives of the study are: to research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself; identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.
Подробное описание
Kidney transplant patients are by definition affected by MRC, regardless of eGFR. However, at the same time, several factors make them a unique category with distant characteristics from non-kidney transplant MRC patients.
Immunosuppressant and corticosteroid therapy could affect a variety of systems, including the pituitary-thyroid-kidney axis. MTOR inhibitors, for example, would result in increased iodine uptake in TSH-stimulated thyrocytes.
Corticosteroids, on the other hand, inhibit the conversion of T4 to T3 and inhibit the TSH production in a dose-dependent manner, and this activity could contribute to the low T3 syndrome that some sturi repot in the phase immediately following kidney transplantation.
In addition, abrupt changes in the serum concentration of thyroid hormones in the immediate post kidney transplantation could be influenced by the stress surgery related to the surgery itself and by exposure to iodinated agents (antiseptics and iodinated contrast medium).
The objectives of the study are:
1. To research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself in terms of:
* Renal function three months after transplantation. * Medical complications in the post-transplant period (from surgery to patient discharge) * Patient survival at three months after transplantation. 2. Identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.
During the past 5 years at the Transplant Center of the Nephrology OU, Dialysis, Transplantation of our hospital, 579 kidney transplants have been performed with an average of about 115 transplants per year. It is therefore estimated for our study a sample size of about 100 patients, given the need to meet the inclusion criteria.
Первичные конечные точки
- Thyroid function [Срок оценки: At baseline, then 3-month follow-up after kidney transplantation]
- Renal function [Срок оценки: At 3-month follow-up after kidney transplantation]
- Medical complications [Срок оценки: Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge]
- Survival [Срок оценки: At 3-month follow-up after kidney transplantation]
Критерии участия
Критерии включения
- Subjects transplanted at our Center;
- Subjects whose 3-month follow-up is available;
- Age ≥18 years;
- Availability of clinical and laboratory data regarding thyroid function trends in the immediate post-transplant period (within 30 days after transplantation);
- Subjects giving informed consent to participate.
Критерии исключения
- None.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Идентификаторы
NCT: NCT06794203 · ITTX-21