- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01943409
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.
There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.
The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
-
-
Ontario
-
Toronto, Ontario, Канада, M5G 2C4
- University Health Network
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Patients 18 years or older
- Patients with PN during their hospitalization
- Patients hospitalized in medical, surgical or ICU wards
- Signed informed consent either from the patient, their legally authorized representative or a direct family member
Exclusion Criteria:
- • Patients without PN during their hospitalization
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
|
soybean oil-based lipid emulsion
|
Экспериментальный: ClinOleic
Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid.
ClinOleic is approved by Health Canada.
The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.
|
olive oil-based lipid emulsion
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Prealbumin
Временное ограничение: at baseline (day 0) and day 10
|
prealbumin is an hepatic protein that is used in the diagnosis of malnutrition.
It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.
|
at baseline (day 0) and day 10
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Length of stay
Временное ограничение: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
Length of stay in the hospital and ICU will be recorded.
We will record how many days it took,since admission to the hospital, for the patient to be discharged.
This is an expected average of 4 weeks of length of stay.
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
Mortality
Временное ограничение: participantes will be followed for the duration of hospital stay, an expected average of 4 weeks
|
We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable.
The expected average of hospital stay is 4 weeks.
|
participantes will be followed for the duration of hospital stay, an expected average of 4 weeks
|
Body mass index
Временное ограничение: Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)
|
We will measure weight before, at day 10 and after PN to calculate the BMI at this different points.
The last day of PN is whenever the patient is taken off PN.
This can vary considerably from patient to patient.
|
Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)
|
Infections
Временное ограничение: until one week post-PN (averag expected 4 weeks)
|
we will record the infections the patients develop during PN until one week after PN
|
until one week post-PN (averag expected 4 weeks)
|
hand-grip strength
Временное ограничение: at baseline (day 0) and day 10 of PN
|
We will measure hand grip strength at baseline (day0) and at day 10 of PN.
This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength
|
at baseline (day 0) and day 10 of PN
|
mid-arm circumference
Временное ограничение: at baseline (day0) and day 10
|
This is a rough indicator of body fat
|
at baseline (day0) and day 10
|
Subjective global assessment (SGA)
Временное ограничение: at baseline (day 0) and day 10
|
is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support
|
at baseline (day 0) and day 10
|
Antibiotic days
Временное ограничение: until one week post PN
|
we will record antibiotic days from the start of PN until one week after PN is discontinued
|
until one week post PN
|
high sensitivity C-reactive Protein (hs-CRP)
Временное ограничение: Baseline (day 0) and day 10
|
hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN
|
Baseline (day 0) and day 10
|
Red blood cell fatty acid composition
Временное ограничение: Baseline (day 0) and day 10
|
Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency
|
Baseline (day 0) and day 10
|
Соавторы и исследователи
Спонсор
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 (Оценивать)
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
- CAPCR ID: 13-5807
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. .