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Набор скоро начнётся NCT07596407

Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment

— Наблюдательное Renal Injury, Acute

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Renal Injury, Acute. Базовые параметры: Без ограничений · 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
Франция
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

Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools

Обзор

Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. These adverse outcomes are thought to result from persistent inflammation, fibrosis, and cardio-renal interactions, which are not adequately captured by conventional clinical or biological markers. This study is an ancillary analysis of the AKIKI 2 trial. The main objective is to assess whether biomarkers of inflammation and fibrosis, specifically galectin-3 (Gal-3) and CD146, measured during the acute phase of AKI, can predict and stratify long-term cardio-renal risk in patients who survived to day 60 after severe AKI in the ICU. The primary endpoint is the occurrence, between day 60 and the last follow-up, of a composite cardio-renal outcome, defined as the first occurrence of: * a major cardiovascular event (myocardial infarction, stroke, or hospitalization for heart failure), * a major renal event (chronic dialysis dependence or progression to severe chronic kidney disease), * or death from any cause. Secondary objectives include : * describing the long-term incidence of major renal events (MAKE), * describing the incidence of major cardiovascular events (MACE), * evaluating the predictive ability of Gal-3 and CD146 for the occurrence of MAKE, * evaluating their ability to predict long-term MACE and deterioration of cardiovascular function. The study population will include patients from the AKIKI 2 trial who are alive at day 60. Follow-up data (creatinine levels, dialysis dependence, cardiovascular events, etc.) will be collected through telephone interviews with patients and their referring physicians. When appropriate, a cardiology referral will be recommended as part of routine clinical care.

Первичные конечные точки

  • Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained [Срок оценки: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.]
Вторичные конечные точки (3)
  • Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained [Срок оценки: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.]
  • Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained [Срок оценки: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.]
  • Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography [Срок оценки: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.]

Критерии участия

Критерии включения

The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.

Критерии исключения

Patients opposed to their participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • Réanimation médico-chirurgicale, Hôpital Avicenne — Bobigny

Идентификаторы

NCT: NCT07596407 · APHP251915

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗