Personalized Nutrition to Improve Recovery in Trauma
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: Nutrition Supplement.
- Кому может быть актуально
- Состояния в реестре: Abdominal Trauma. Базовые параметры: от 15 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
- США
- 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
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma
Обзор
The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.
Подробное описание
Severe abdominal trauma can impact patients in a variety of ways. Current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (IV) nutrition will improve outcomes. Participants will be randomly assigned 1:1, like flipping a coin, to the SeND Home program or routine care.
Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. This may include TPN.
Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery. Indirect calorimetry will be used to determine nutrition needs.Once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge.
Participants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.
Вмешательства
- Пищевая добавка Nutrition Supplement
Total parenteral nutrition (TPN) will be administered within 72 hours of abdominal surgery. Nutritional shakes will be started with a liquid diet and given 3 times a day. This will continue for 4 weeks after discharge.
Первичные конечные точки
- Change in six-minute walk distance (6 MWD) [Срок оценки: 3 months]
Вторичные конечные точки (10)
- Change in physical function [Срок оценки: baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge]
- Change in muscle strength [Срок оценки: baseline, hospital discharge, 3 and 6 months post-hospital discharge]
- Change in muscle mass [Срок оценки: baseline, hospital discharge, 3 and 6 months post-hospital discharge]
- Change in Quality of Life (QoL) [Срок оценки: baseline, 3 and 6 months post-hospital discharge]
- Change in cognition [Срок оценки: baseline, 3 and 6 months post-hospital discharge]
- Infection [Срок оценки: hospital discharge, 3 and 6 months post-hospital discharge]
- Length of Hospital/ICU stay [Срок оценки: hospital discharge]
- Mortality rate [Срок оценки: 6 months post-hospital discharge]
- Change in muscle mitochondrial metabolism [Срок оценки: admission, day 14, and hospital discharge]
- Change in key resilience and inflammation biomarkers [Срок оценки: admission, day 14, and hospital discharge]
Критерии участия
Критерии включения
- 15+ years old
- Penetrating abdominal trauma requiring emergent major abdominal surgery
- Admitted to the surgical ICU
- Not expected to receive oral nutrition for 72 hours or more
Критерии исключения
- Patients who are unable to ambulate at baseline
- Expected withdrawal of life-sustaining treatment within 48 hours
- Prisoners
- Positive pregnancy test for women of child bearing potential.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Duke University Hospital — Durham
Идентификаторы
NCT: NCT06065202 · Pro00112343