Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- Phase angle
研究概览
简要总结
The currently recruiting randomised controlled trial "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (INTENT, NCT03292237) is the first multi-centre trial to compare an intensive, individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients. INTENT-Muscle, is an observational longitudinal study nested within INTENT. The aim of INTENT-Muscle is to compare longitudinal changes in muscle health (assessed by bioimpedance and muscle ultrasound) in critically ill patients randomised to each arm of INTENT.
详细描述
Background: Critically ill patients may experience debilitating loss of muscle mass and strength, leading to substantial functional impairments both during and long after hospitalisation. Little is known about what therapies may attenuate deterioration of muscle health (muscle mass and muscle quality) in this setting but nutrition is thought to be important, based on the physiological response to critical illness.
The currently recruiting randomised controlled trial (RCT) "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (ClinicalTrials.gov Identifier: NCT03292237) is the first multi-centre trial to provide an individualised nutrition intervention for the duration of hospital admission in critically ill patients. Combining the most promising and novel bedside techniques for objectively measuring muscle health (bioimpedance technology and ultrasound) with a whole hospital nutrition intervention has never been done before, and will provide crucial data to understand the relationship between nutrition delivery and changes in muscularity from ICU admission to hospital discharge.
Aim: To explore changes in muscle health in response to an individualised nutrition intervention and in association with clinical and functional outcomes, using clinically applicable bedside techniques.
Secondary aims:
In both arms of INTENT to:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomised to the INTENT trial at a participating sub-study site
排除标准
- •Patients will be excluded from the sub-study if they have any of the following:
- •A pacemaker or electronic implantable device
- •Missing limb(s)
- •Unable to get adequate separation in the limbs (e.g. severe obesity)
- •Inaccessible site(s) for electrode placement (e.g. major burns, trauma)
- •Broken skin at the site(s) of electrode placement
- •The treating clinician does not believe the study to be in the best interest of the patient
- •Person responsible/Medical treatment decision maker is of non-English speaking background (therefore cannot provide informed consent) Note Before: If the Person responsible/medical treatment decision maker is of English speaking background but the patient is not (and the Person responsible/Medical treatment decision maker speaks the same language as the patient) you may continue assessing the patient for eligibility to INTENT-Muscle as the Person Responsible/Medical treatment decision maker can translate the Patient Information and Consent Form (PICF) and consent discussion with the patient in order to obtain continuing consent)
结局指标
主要结局
Phase angle
时间窗: Hospital admission (censored at study day 28)
To compare longitudinal changes in phase angle during hospital admission in patients randomised to both arms of INTENT.
次要结局
- Change in BIS-derived normally-hydrated lean tissue(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived characteristic frequency (ωc, a Cole model variable)(Every 7 days during hospital admission (censored to study day 28))
- Change in bioelectrical impedance spectroscopy (BIS) derived phase angle(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived impedance ratio(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived fat-free mass(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived extra-cellular water(Every 7 days during hospital admission (censored to study day 28))
- Change in ultrasound-derived bilateral quadriceps muscle thickness(Every 7 days during hospital admission (censored to study day 28))
- Change in ultrasound-derived Rectus femoris echogenicity(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived intracellular water(Every 7 days during hospital admission (censored to study day 28))
- Muscle mass at ICU admission(Baseline (Enrolment))
- Change in BIS-derived Cole model variable R infinity to R0(Every 7 days during hospital admission (censored to study day 28))
- Change in BIS-derived membrane capacitance (a Cole model variable)(Every 7 days during hospital admission (censored to study day 28))
- Change in ultrasound-derived Rectus femoris cross-sectional area(Every 7 days during hospital admission (censored to study day 28))
- Change in ultrasound-derived mid-upper arm muscle thickness(Every 7 days during hospital admission (censored to study day 28))