- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04555382
Combining CAF, L-FABP and NGAL as a Potentially Diagnostic Model for Acute Kidney Injury.
Association Between CAF, L-FABP and NGAL and the Occurence of Acute Kidney Injury : a Potential Diagnostic Model of Three Biomarkers.
Acute kidney injury was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of AKI.
This observational cohort study included one hundred patients who had been in ICU from the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. Blood and urine samples were collected every 12 hours until 7 days. The time of staying with ICU less than 2 days were removed. CAF, L-FABP and NGAL was measured based on the platform of Chemiluminescent Immunoassay, and assessed the diagnostic value of the occurrence of AKI. By constructing an effective diagnostic model to provide effective clinical decision-marking for early intervention.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The observational cohort study included one hundred patients who were from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines as renal function was suddenly decreased within 48 hours and serum creatinine increased at least 0.3mg/dL, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours. The staging criteria of AKI as follows: stage I means serum creatinine higher than baseline between 1.5times and 1.9 times, or serum creatinine increased at least 26.5μmol/L, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours; stage II means serum creatinine higher than baseline between 2.0 times and 2.9 times, or urine volume less than 0.5mL/Kg per hour for 12hours; stage III means serum creatinine higher than baseline 3.0 times, or serum creatinine higher than baseline 353.6μmol/L, or started renal replacement therapy. Patients who stayed in the ICU for less than 24 hours and whose serum creatinine had increased above normal reference range on the first day of ICU were excluded.
Collecting the blood and urine samples of the patients regularly every twelve hours, centrifuging samples in 3000rpm for 5 minutes, freezing at -80℃, all patients' clinical information should be recorded by name, age ,sex, BMI index, hypertension, diabetes, cardiac disease, and so on. All patients have written informed contents and this study was approved by the Second Affiliated Hospital of Zhejiang University School of Medicine.NGAL, CAF and L-FABP was measured by chemiluminescent immunoassay with Robust i1000.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай
- Рекрутинг
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
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Контакт:
- Wang Weilin
- Номер телефона: +86 0571 87783759
- Электронная почта: keyanlunli_zheer@163.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- the serum creatinine was increased above reference range at first when patients were included intensive care unit;
- renal dialysis and plasma exchange were never occured when patients were included in the study;
- patients who were included in the study stayed at two days in ICU.
Exclusion Criteria:
- patients who stayed in ICU for less than 24 hours;
- the serum creatinine was increased above reference range before ICU admission;
- kidney-related diseases were existed before ICU admission.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Когорта
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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AKI group
this group are included patients who have not occured acute kidney injury at first, however acute kidney injury are occured soon afterwards during the observation period.
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Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
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non-AKI group
this group are included patients who have not occured acute kidney injury during the observation period.
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Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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the concentration of CAF, L-FABP and NGAL
Временное ограничение: seven days after admission
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the concentration of CAF, L-FABP and NGAL of blood and urine samples of every patients are measured by Chemiluminescent Immunoassay
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seven days after admission
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Соавторы и исследователи
Следователи
- Учебный стул: Tao Zhihua, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2020-791
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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