- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01420302
LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-1)
LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
- Withdrawal of the informed consent
- Patient starts eating or drinking sugar containing liquids
- Patient is discharged from the ICU (including ICU deaths)
- Removal of arterial line or central venous line
Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:
- Recurrent severe hypoglycemia (<40 mg/dL)
- Refractory hyperglycemia
- Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician
The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 3
Контакты и местонахождение
Места учебы
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Leuven, Бельгия, 3000
- Dept Intensive Care Medicine, University Hospitals Leuven
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 18 years or more
- Admitted to the ICU
- Already receiving or needing insulin infusion for blood glucose control
Exclusion Criteria:
- Not critically ill (eating, not mechanically ventilated)
- Pregnant or breastfeeding
- Previous inclusion into the trial
- Included in other trial
- Moribund
- Diabetes coma
- No arterial line available
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
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Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
Другие имена:
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Активный компаратор: Nurse-directed
Nurse-directed blood glucose control (80-110 mg/dL)
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Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Glycemic Penalty Index (GPI) during the intervention
Временное ограничение: up to 14 days post-randomization
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Adequacy of reaching and maintaining the target range for blood glucose during the intervention
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up to 14 days post-randomization
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Proportion of patients with severe hypoglycemia (<40 mg/dL) during the intervention
Временное ограничение: up to 14 days post-randomization
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Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention
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up to 14 days post-randomization
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Incidence of severe hypoglycemia (<40 mg/dL) during the intervention
Временное ограничение: up to 14 days post-randomization
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Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention
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up to 14 days post-randomization
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Blood glucose level per treatment group during the intervention
Временное ограничение: up to 14 days post-randomization
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up to 14 days post-randomization
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Hyperglycemic index (HGI) during the intervention
Временное ограничение: up to 14 days post-randomization
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Adequacy of reaching and maintaining the target range for blood glucose during the intervention
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up to 14 days post-randomization
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Daily maximal blood glucose difference during the intervention
Временное ограничение: up to 14 days post-randomization
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Marker of blood glucose variability
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up to 14 days post-randomization
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Proportion of patients with common hypoglycemia (<60 mg/dL) during the intervention
Временное ограничение: up to 14 days post-randomization
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Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention
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up to 14 days post-randomization
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Interval between blood glucose measurements during the intervention
Временное ограничение: up to 14 days post-randomization
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Marker of workload
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up to 14 days post-randomization
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Percentage of time in target zone (80-110 mg/dL) during the intervention
Временное ограничение: up to 14 days post-randomization
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Adequacy of reaching and maintaining the target range for blood glucose during the intervention
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up to 14 days post-randomization
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Length of stay in ICU
Временное ограничение: up to 90 days post-randomization
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up to 90 days post-randomization
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Length of stay in hospital
Временное ограничение: up to 90 days post-randomization
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up to 90 days post-randomization
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Hospital mortality
Временное ограничение: up to 90 days post-randomization
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Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors
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up to 90 days post-randomization
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Incidence of common hypoglycemia (<60 mg/dL) during the intervention
Временное ограничение: up to 14 days post-randomization
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Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention
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up to 14 days post-randomization
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Dieter Mesotten, MD, PhD, KU Leuven
- Главный следователь: Greet Van den Berghe, MD, PhD, KU Leuven
- Главный следователь: Tom Van Herpe, Eng, PhD, KU Leuven
- Главный следователь: Bart De Moor, Eng, PhD, KU Leuven
Публикации и полезные ссылки
Общие публикации
- van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Van Herpe T, De Brabanter J, Beullens M, De Moor B, Van den Berghe G. Glycemic penalty index for adequately assessing and comparing different blood glucose control algorithms. Crit Care. 2008;12(1):R24. doi: 10.1186/cc6800. Epub 2008 Feb 26.
- Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. doi: 10.1016/j.bpa.2008.07.003.
- Van Herpe T, Mesotten D, Wouters PJ, Herbots J, Voets E, Buyens J, De Moor B, Van den Berghe G. LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness: the LOGIC-1 single-center, randomized, controlled clinical trial. Diabetes Care. 2013 Feb;36(2):188-94. doi: 10.2337/dc12-0584. Epub 2012 Sep 6.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
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
- LOGIC-Insulin 1.1.1.
- S 51956 (Другой идентификатор: University Hospitals Leuven)
- 80M0437 (Другой идентификатор: Belgian Federal Agency for Medicines and Health Products)
- ML 6079 (Другой идентификатор: IRB)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования LOGIC-Insulin
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ExactechРекрутингЭндопротезирование коленного сустава, всегоИспания
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Rabin Medical CenterПрекращеноДиабет 1 типаИзраиль
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Rabin Medical CenterNovo Nordisk A/S; DreaMedПрекращено
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Rabin Medical CenterMedtronicЗавершенный
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The Cleveland ClinicGebauer CompanyЗавершенный
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KU LeuvenAgentschap voor Innovatie door Wetenschap en TechnologieЗавершенныйГипергликемия | Гипогликемия | Критических заболеванийБельгия, Нидерланды
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Rabin Medical CenterОтозван
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Rabin Medical CenterGIFОтозванДиабет 1 типаГермания, Израиль
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Michael TsoukasAdociaРекрутинг