Идёт набор NCT07338669

Hamburg Acute Renal Injury Study (HARIS)

— Наблюдательное Acute Kidney Injury Acute Kidney Injury (AKI)

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: Acute Kidney Injury, Acute Kidney Injury (AKI). 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: Германия
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

Hamburg Acute Renal Injury Study

Обзор

The Hamburg Acute Renal Injury Study (HARIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.

Подробное описание

The Hamburg Acute Renal Injury Study (HARIS) is a prospective observational cohort study that includes hospitalized adults (≥18 years) at the time of acute kidney injury (AKI). Potential participants are identified during hospital care, and a structured IT-supported clinical screening system helps detect AKI cases in real time. In parallel, a control group of hospitalized adults with acute illness who have not developed AKI is enrolled to enable comparative analyses of specific risk factors, pathophysiology, and outcomes. All participants undergo a standardized clinical assessment of kidney function, comorbidities, hemodynamic status, medication exposure, procedures, and laboratory parameters. The study includes serial collection of clinical data and biosamples (blood and urine) at study inclusion, during hospitalization, and at 3-month after discharge. All biospecimens are processed within a harmonized pipeline and stored in the Hamburg and European Renal Omics-Biobank (HERO). Beyond the identification of clinical determinants of AKI trajectories, the central objective of HARIS is to identify biological pathways of sustained kidney injury and repair, improve risk stratification, evaluated prognostic biomarkers, and support the development of precision medicine approaches in post AKI care. Long-term outcomes including progressive chronic kidney disease, cardiovascular events, hospital readmissions, and mortality are collected through annual structured follow-ups. No experimental interventions are performed and all clinical management follows standard of care.

Первичные конечные точки

Kidney Function Recovery after AKI [Срок оценки: assessed at discharge, 3-months after discharge, and annual follow-up]
Persistent Kidney Function Decline [Срок оценки: assessed at discharge, 3-months after discharge, and annual follow-up]
Development or Progression of Chronic Kidney Disease [Срок оценки: assessed at 3-months after discharge, and annual follow-up]
End-stage kidney disease (ESKD) [Срок оценки: assessed at discharge, 3-months after discharge, and annual follow-up]
Renal mortality [Срок оценки: assessed at discharge, 3-months after discharge, and annual follow-up]
Cardiovascular Outcomes [Срок оценки: assessed at discharge, 3-months after discharge, and annual follow-up]

Вторичные конечные точки (5)

Incidence of vascular diseases [Срок оценки: assessed at discharge, 3 months after discharge, and annual follow-up]
Incidence of Dementia [Срок оценки: assessed at discharge, 3 months after discharge, and annual follow-up]
Incidence of Cancer [Срок оценки: assessed at discharge, 3 months after discharge, and annual follow-up]
Incidence of Infections [Срок оценки: assessed at discharge, 3 months after discharge, and annual follow-up]
Incidence of psychosomatic or Psychiatric Disorders [Срок оценки: assessed at discharge, 3 months after discharge, and annual follow-up]

Критерии участия

Критерии включения

Hospitalized individuals with acute kidney injury (AKI), defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria or hospitalized individuals with acute illness who have not developed AKI (control group)
Age ≥ 18 years at time of enrollment
Personally signed informed consent