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Идёт набор NCT04502511

Heterogeneity of Critical Illness: a Cohort Study

— Наблюдательное Critically Ill Organ Failure, Multiple

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: Standard diagnosis test.
Кому может быть актуально
Состояния в реестре: Critically Ill, Organ Failure, Multiple. 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
Нидерланды
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

Heterogeneity of Critical Illness: Exploring New Risk Factors for Severity of Disease in Intensive Care Patients. A Cohort Study

Обзор

Rationale: There is large heterogeneity in disease states of critically ill patients at ICU admittance and there is also large heterogeneity in their disease severity during ICU stay. Still, some patients may show remarkable similarities in disease patterns. There is a lack of understanding of causal mechanisms that lead to divergent outcomes in critically ill patients, and at the same time different diseases may share common underlying, yet unidentified, causal pathways that could explain similarities between different diseases. Objective: To explore the association between patient characteristics and the severity of organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort study Study population: Adult critically ill patients in the ICU Intervention (if applicable): not applicable Main study parameters/endpoints: Maximum severity of organ failure observed during ICU stay measured by the maximum SOFA score and quality of life at one year follow-up

Подробное описание

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: \<All patients will undergo physical examination, including ultrasound evaluation upon ICU admission according to standard practice care. The burden will be a blood sample (and urine sample) at admission. Blood sample will be obtained by arterial line (or venous access) which is part of standard ICU care. So there will be no additional puncture for this study. Collection of variables during ICU stay will all be either part of standard clinical care or include extra physical examination or ultrasound evaluation. For follow-up patients will be evaluated by phone at 6 months and at 12 months by home-visit. This is also already part of the investigator's evaluation of quality of care. Except for blood sampling, all study related procedures have previously been approved by the Institutional Review Board (IRB). The patient will experience no individual benefit.

Вмешательства

  • Диагностический тест Standard diagnosis test
    Care as usual

Первичные конечные точки

  • Severity of organ failure observed during ICU stay [Срок оценки: During ICU admission with a maximum of 90 days]
Вторичные конечные точки (1)
  • Follow-up Quality of life data [Срок оценки: 6 and 12 months after ICU discharge]

Критерии участия

Критерии включения

  • Adults Definition: age ≥18 years.
  • Emergency admission to the ICU Definition: patients who are acutely admitted to the ICU due to acute or unexpected critical illness, either from the emergency department or the ward or transferred from an ICU (or a ward) from another hospital.

Критерии исключения

  • Planned admission
  • Absence of an invasive arterial or venous line for blood sampling.
  • Any continued cardiopulmonary resuscitation efforts upon admission which limit access to the patient for research activities.
  • Main ICU admission reason chronic (non-invasive) home ventilation
  • Main ICU admission reason normothermic treatment after cardiac arrest
  • Main ICU admission reason ischemic stroke, intracerebral bleeding, or isolated neurotrauma
  • Main ICU admission reason Coronavirus Disease 2019 (COVID-19)
  • Solid organ or hematopoietic stem cell transplant during current hospital admission
  • Strict isolation due to any contagious disease
  • No informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • University Medical Center Groningen — Groningen

Публикации

  • van der Aart TJ, Luxen M, Koeze J, Londen MV, Hackl M, Ter Maaten JC, van Meurs M, Bouma HR; the Acutelines research group. Validation of plasma microRNAs as biomarkers in sepsis associated acute kidney injury upon first clinical presentation reveals limited diagnostic and prognostic performance. PLoS One. 2025 Sep 4;20(9):e0331442. doi: 10.1371/journal.pone.0331442. eCollection 2025. PMID 40906653

Идентификаторы

NCT: NCT04502511 · 202000405

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗