- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07591402
Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock. (SEPSMET)
Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock: a Multicentre Retrospective Cohort Study.
Обзор исследования
Подробное описание
Septic shock is one of the leading causes of admission to intensive care units (ICU), with an incidence of approximately 19 million patients per year worldwide. Despite progress made in the management of patients suffering from this condition, mortality and morbidity remain high and show little improvement. Indeed, according to studies, the mortality rate of septic shock ranges from 25 to 30%. Diabetic patients, due to their susceptibility to infections and greater vulnerability, represent a significant proportion of patient cohorts in septic shock. Moreover, diabetes is a factor of poor prognosis during septic shock.
Metformin, an oral anti-diabetic treatment, is currently considered the first-line therapy for type 2 diabetes. It modifies glucose metabolism by inhibiting, notably at the mitochondrial level, the electron transport chain through the inhibition of complex I. This inhibition of complex I decreases mitochondrial production of Adenosine Triphosphate (ATP) and induces activation of AMPK, a key enzyme in energy metabolism. Thus, metformin is responsible for an increase in glycolysis and an inhibition of gluconeogenesis in the liver.
During septic shock, mitochondrial ATP production is limited due to decreased arterial oxygen transport, leading to tissue hypoxia and mitochondrial dysfunction. This results in increased anaerobic energy production through activation of glycolysis, and consequently, increased lactate production responsible for metabolic acidosis. Several studies focusing on septic shock have observed that hyperlactatemia during the initial hours of management is a factor of poor prognosis.
Given the alterations in mitochondrial metabolism caused by metformin, which may exacerbate hyperlactatemia, its potential accumulation in cases of acute renal failure, the hepatic metabolism of lactate, and the deleterious consequences of lactic metabolic acidosis, it is recommended to discontinue metformin during septic shock. However, despite these recommendations, some studies suggest a lower mortality rate in septic shock patients treated with metformin, despite older age, higher rates of cardiovascular disease, and renal failure.
The first hypothesis is that patients on metformin may have better adaptation of their energy metabolism during a significant drop in oxygen supply (a mitochondrial adaptive mechanism reducing energy needs), which limits oxidative stress and its harmful effects. The second hypothesis is that metformin has an immunomodulatory role, resulting in a more moderate inflammatory response in case of infection, and thus less endothelial and visceral dysfunction. Thus, metformin, through modification of mitochondrial metabolism, appears to have pleiotropic, anti-inflammatory, antithrombotic, and vasoactive effects that could be beneficial in septic shock. The benefit of metformin in patients with septic shock therefore needs to be clarified through well-conducted large cohort studies.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Paris, Франция, 75010
- Unité de Recherche Clinique Paris Saclay
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Patients with type 2 diabete
- admitted for septic shock to ICU (APHP) , from July 2017 to September 2022.
Exclusion Criteria:
- Patients under the age of 18,
- without electronical medical record,
- whithout any information about their antidiabetic treatment and those with multiple ICU hospitalization.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Patients who receiving metformin before the inclusion
Patients with type 2 diabete admitted to ICU for septic shock who receiving metformin before the inclusion
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Patients who receiving other antidiabetic drugs before the inclusion
Patients with type 2 diabete admitted to ICU for septic shock who receiving other antidiabetic drugs before the inclusion
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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30-day mortality
Временное ограничение: 30 days
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The primary objective of this study is to evaluate the effect of metformin treatment on mortality in septic shock among type II diabetics patients. The primary endpoint is mortality within a 30-day time frame following admission to the intensive care unit. |
30 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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90-day mortality
Временное ограничение: 90 days after ICU admission.
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Evaluate the effect of metformin treatment on mortality at 90 days after ICU admission.
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90 days after ICU admission.
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Multiorgan failures
Временное ограничение: From ICU admission to ICU discharge (up to 30 days)
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Number of patients with at least one organ failure, defined by the presence of ≥1 ICD-10 diagnosis code for renal, hemodynamic, cardiac, respiratory, or hepatic failure.
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From ICU admission to ICU discharge (up to 30 days)
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Duration of vasopressor use
Временное ограничение: From ICU admission to ICU discharge (up to 30 days)
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Duration of vasopressor use, defined as the cumulative number of days with administration of vasopressors based on repeated CCAM code EQLF003 (each code corresponding to 24 hours of therapy)
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From ICU admission to ICU discharge (up to 30 days)
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Mechanical ventilation
Временное ограничение: From hospital admission to hospital discharge (up to 30 days)
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Number of patients with mechanical ventilation, defined by the presence of ≥1 CCAM procedure code for mechanical ventilation
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From hospital admission to hospital discharge (up to 30 days)
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Acute Kidney Injury (AKI)
Временное ограничение: From ICU admission to ICU discharge (up to 30 days)
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Number of participants with acute kidney injury (AKI), defined according to the Kidney Disease Improving Global Outcomes (KDIGO)
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From ICU admission to ICU discharge (up to 30 days)
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Соавторы и исследователи
Следователи
- Главный следователь: Marie Werner, MD, Service d'Anesthésie Réanimation Chirurgicale, DMU 12 Anesthésie Réanimation Chirurgicale Médecine Péri-opératoire et Douleur, Hôpital Bicêtre, AP-HP, Université Paris-Saclay, Le Kremlin-Bicêtre, France
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
- APHP240993
- CSE 19-0019 (Другой идентификатор: CSE)
Планирование данных отдельных участников (IPD)
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Данные исследования/документы
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.
продукт, произведенный в США и экспортированный из США.
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