CONvalescence of FUntional Outcomes After ICU Stay by Oral Protein Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
研究概览
简要总结
Study the effect of 6-weeks porcine protein supplementation vs isocaloric comparator (carbohydrate) on functional outcomes in post ICU-patients. Patients will be included at ICU discharge. Included patients will receive the supplements twice daily (morning and afternoon), starting at the first day at the general ward.
To the best of our knowledge, a study on protein supplementation in the post-ICU period to address its effect on functional outcomes is lacking.
详细描述
Patients discharged from the Intensive Care Unit frequently suffer from Post Intensive Care Syndrome. This syndrome is characterized by muscle weakness and physical disabilities besides neurocognitive and psychological disturbances. Studies have shown that protein requirements in the post-ICU phase are often not met. Furthermore, protein supplementation in other patient groups have shown beneficial effects. However, a study on protein supplementation during the post-ICU period is lacking. This study aims to investigate the effect of protein supplementation on functional outcomes in post-ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical non-transparent sachets with circle or square
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
- •Age ≥ 18 years
- •Living at home before hospital admission
- •Minimum ICU stay of 72 h
- •Informed consent
排除标准
- •MRC sum score ≤24 or 48≥ at ICU discharge
- •Barthel Index <14 before ICU admission
- •Chronic home ventilation
- •Mitochondrial or muscle disease or pareses
- •Serum creatinine > 173 mcmol/l (renal dysfunction)
- •Treatment limitations: DNR, no ICU readmission or palliative care
- •Inclusion in another intervention trial since ICU admission
- •Intolerance or allergy (for study products)
- •People living in a nursing home before hospital admission
- •Chronic Organizing Pneumonia or Pulmonary Interstitial Fibrosis
- •Inflammatory Bowel Disease
- •Diabetes Mellitus pharmaceutical medication at ICU admission
- •Underlying disease in which in the eyes of the attending physician, the protein or carbohydrate supplement could form a risk for the patient.
结局指标
主要结局
Between group difference in composite score over time. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity.
时间窗: At 3-months follow-up
Between-group difference in physical function over time expressed as a composite score. The composite score consists of handgrip strength, muscle strength leg, muscle strength arm and exercise capacity. Handgrip strength will be measured with the Jamar dynamometer Muscle strength leg will be measured with the handheld dynamometer m. quadriceps fem. Muscle strength arm will be measured with the handheld dynamometer bicepss brachii Exercise capacity will be measured with the 6 minute walking distance test. Measured values will be compared to normative data. Calculated percentages will be added up and together form the composite score.
次要结局
- Muscle strength and function (Medical Research Council-sumscore)(At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up)
- Muscle strength leg(6 weeks after ICU discharge (end of the intervention))
- Muscle strength arm(6 weeks after ICU discharge (end of the intervention))
- Muscle mass(At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up)
- Health related quality of life(At hospital discharge (an average of 11 days), 6 weeks after ICU discharge (end intervention) and 3 months follow-up)
- Muscle strength and function (Chelsea Critical Care Physical Assessment Tool)(At hospital discharge, an average of 11 days)
- Laboratory evaluation(6 weeks after ICU discharge (end intervention))
- Handgrip strength(6 weeks after ICU discharge (end of the intervention))
- Functional performance(6 weeks after ICU discharge (end intervention))
- Clinical endpoint hospital readmission(6 weeks after ICU discharge (end intervention) and 3 months follow-up)
- Clinical endpoint ICU readmission(6 weeks after ICU discharge (end intervention) and 3 months follow-up)
- Exercise capacity(6 weeks after ICU discharge (end of the intervention))
- Lower extremity muscle strength(6 weeks after ICU discharge (end of the intervention))
- Clinical endpoint survival(6 weeks after ICU discharge (end intervention) and 3 months follow-up)
研究者
ARH van Zanten
Prof. Dr. ARH van Zanten, MD, PhD
Gelderse Vallei Hospital