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Идёт набор NCT06521086

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Без фазы С лечением Trauma Critical Illness

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 Supplements - Fresubin KCAL Drinks.
Кому может быть актуально
Состояния в реестре: Trauma, Critical Illness. Базовые параметры: от 45 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

Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life

Обзор

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Подробное описание

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.

Subjects will be randomized 1:1 to enhanced nutrition or control arm. Subjects randomized enhanced nutrition oral nutrition supplements (Fresenius KCAL shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers.

Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.

Вмешательства

  • Пищевая добавка Nutrition Supplements - Fresubin KCAL Drinks
    Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Первичные конечные точки

  • Change in muscle mass as a measure of muscle quality [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in glycogen stores as a measure of muscle quality [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
Вторичные конечные точки (5)
  • Change in six minute walk test (6MWT) distance [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in four meter gait speed [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in 30-second sit to stand test [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in grip strength [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]
  • Change in quadriceps strength [Срок оценки: Baseline to one month post-discharge (approximately six weeks)]

Критерии участия

Критерии включения

  • Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma
  • Patients who have the ability to tolerate oral nutrition
  • Patients who have had a standard of care CT scan this admission

Критерии исключения

  • Expected withdrawal of life-sustaining treatment within 48 hours
  • Traumatic Brain Injury
  • Presence of lower extremity fracture(s)
  • Mechanical Ventilation
  • Subjects for who the Investigator would recommend a different supplement based on their medical condition.
  • Prisoner
  • Pregnancy 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
Профилактика

Центры проведения

США · 1 центр
  • Duke University Hospital — Durham

Идентификаторы

NCT: NCT06521086 · Pro00114950

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗