Набор скоро начнётся NCT06929637

Amino Acid Infusion in Kidney Transplant Recipients

Без фазы С лечением Short-term Graft Function Metabolic Effects Nutritional Effect Immunological &Amp; Inflammatory Markers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Infusion Therapy, Saline solution infusion.
Кому может быть актуально: Состояния в реестре: Short-term Graft Function, Metabolic Effects, Nutritional Effect, Immunological &Amp; Inflammatory Markers. 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: Словакия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Amino Acid Infusion on Early Graft Function After Kidney Transplantation

Обзор

The study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.

Подробное описание

Background and Rationale: Delayed graft function (DGF) remains a significant challenge in kidney transplantation, particularly in recipients of deceased donor organs. DGF, often defined as the need for dialysis within the first post-transplant week, is associated with poorer long-term graft survival and increased immunological risk. Ischemia-reperfusion injury (IRI) plays a crucial role in the pathogenesis of DGF, contributing to oxidative stress, inflammation, and endothelial dysfunction. Strategies to mitigate IRI and enhance early graft recovery are highly sought after.

Amino acids play a critical role in cellular metabolism, protein synthesis, and immunomodulation. Prior research suggests that amino acid supplementation may improve nitrogen balance, enhance mitochondrial function, and reduce oxidative stress, potentially benefiting graft recovery. However, there is limited clinical evidence assessing whether perioperative amino acid administration improves graft function in kidney transplant recipients. The AID-KT study aims to evaluate the impact of intravenous amino acid infusion on early graft function following kidney transplantation.

Study Design: AID-KT is a prospective, interventional cohort study with a retrospective control group. The intervention group will receive intravenous amino acid (AA) supplementation at a dose of 1g/kg body weight daily for three days post-transplant. The historical control group consists of kidney transplant recipients from previous years who did not receive amino acid infusion. The study will evaluate graft function, metabolic response, and patient outcomes over a 12-month follow-up period.

Вмешательства

Препарат Infusion Therapy
Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure
Препарат Saline solution infusion
Infusion of saline solution a s standard rehydration therapy after kidney transplantation

Первичные конечные точки

Improving graft function 3 months after kidney transplantation [Срок оценки: 90 days after enrollment/kidney transplantation]

Вторичные конечные точки (8)

Decrease of the biopsy proven acute rejection incidence [Срок оценки: 90 days after enrollment]
Improving levels of total proteins and albumin [Срок оценки: 90 days after enrollment/kidney transplantation]
Lipid profile improvement [Срок оценки: 90 days after enrollment/kidney transplantation]
Decreasing the incidence of delayed graft function [Срок оценки: 7 days after enrollment / kidney transplantation]
Monitoring the incidence of severe hyperkalemia [Срок оценки: 90 days after enrollment/kidney transplantation]
Monitoring the incidence of metabolic acidosis [Срок оценки: 90 days after enrollment/kidney transplantation]
Monitoring the incidence of elevated liver enzymes [Срок оценки: 90 days after enrollment/kidney transplantation]
Monitoring the incidence of elevated bilirubin [Срок оценки: 90 days after enrollment/kidney transplantation]

Критерии участия

Критерии включения

Adult patients (≥18 years) undergoing deceased or living donor kidney transplantation
First-time kidney transplant recipients
No known allergy or contraindication to amino acids
Stable hemodynamic status post-transplant
Signed informed consent