Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional Status Score for ICU (FSS-ICU)
概览
简要总结
A Pilot Randomized Controlled Trial (RCT) will be conducted where where mechanically ventilated patients will be randomized to optimal protein (Achieve 80% protein supplementation adequacy with daily titration) versus standard protein feeding. Both groups will receive standard usual early exercise therapy.
Specific aim 1: To determine if optimal protein supplementation improves functional outcome of patients as measured by Functional Status Score (FSS) on Day 7.
Specific aim 2: To determine if optimal protein supplementation reduces muscle loss of patients at Day 7 as measured by the Rectus Femoris thickness and cross-sectional area (RFCSA) using skeletal muscle ultrasound.
Specific aim 3: To determine difference in functional recovery between groups using quality of life (QOL) scores and 6-minute walk distance at 3 months after hospital discharge.
The hypothesis is protein inadequacy can be overcome with optimized protein supplementation to reduce muscle loss/sarcopenia and functional impairment in ICU survivors.
详细描述
This study will be a prospective pilot randomized controlled trial. Collaboration will be between the National University Hospital (Medical, Surgical and Cardiothoracic ICUs), Centre for Healthy Aging, National University Health System (NUHS) and Physical Education & Sports Science, National Institute of Education (NIE). Patients admitted into these ICUs will be screened and those meeting the inclusion criteria will be approached for consent. If the patient is unable to consent, his/her legally acceptable representatives will be approached. This approach is routinely done in ICU studies. As with other ICU studies, potential difficulties in consenting and recruiting patients will be expected. To overcome this, all adult ICU patients at NUH will be included in the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participants and their legally acceptable representative will not be made known of the experimental arms that the participant is allocated to.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years and above.
- •Expected mechanical ventilation duration ≥ 48 hours.
- •Expected to stay in hospital for ≥ 4 days.
排除标准
- •Pregnant woman.
- •Amputation of either lower limbs.
- •Surgery of lower limb during the current admission.
- •Any neurological/rheumatologic/orthopaedic/burn/trauma/physiological problem with feeding difficulties during 48h of intubation
- •Wheelchair-bound, walking aids and ADL-dependent.
- •Patient not able to feed by 48 hours AND not given parenteral feeding.
- •Patients on Continuous Renal Replacement Therapy.
- •Sepsis with poor prognosis.
- •Competing trial
- •Moribund within 48hours.
结局指标
主要结局
Functional Status Score for ICU (FSS-ICU)
时间窗: Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
It is an ordinal score consisting of 5 activities (namely, Rolling in bed, Supine to Sit Transfer, Sit to Stand Transfer, Sitting Edge of Bed, Walking); each activity is scored from 0 to 7 to a total of 35. A higher score indicates a better functioning. It closely resembles Activities of Daily Living (ADL) and it is possible to even measure the pre-admission score. The FSS-ICU is measured at day 1 upon recruitment and compared to a one week period and to the time of discharge in intensive care to determine functional improvements at these time points.
次要结局
- Clinical Frailty Index (CFI)(Day 1 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission)
- Indirect calorimetry (IC)(Day 1 to Day 7 of Randomisation (daily or till extubation))
- Blood Biomarkers(Day 1 of Randomisation; Day 4 of Randomisation)
- Six-Minute Walk Test (6MWT)(3 months post hospital discharge)
- Rectus Femoris Cross-Sectional Area (RFCSA) and anterior thigh and rectus femoris thickness(Day 1 of Randomisation; Day 4 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission)