EUCTR2018-003703-19-DE进行中（未招募）1 期
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial - EFFORTcombo
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty0 个研究点目标入组 142 人开始时间: 2019年5月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. =18 years old;
- •2. Expected to remain mechanically ventilated for an additional 48 hours from screening;
- •3. And have one or more of the following risk factors that make them at high nutritional risk:
- •a.Low (=25) or High BMI (=35)
- •b.Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
- •c.Frailty (Clinical Frailty Scale 5 or more from proxy)
- •d.Sarcopenia (SARC-F score of 4 or more from proxy)
- •e.From point of screening, projected duration of mechanical ventilation >4 days
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1.>96 continuous hours of mechanical ventilation before enrollment
- •2.Expected death or withdrawal of life-sustaining treatments within 7 days from screening
- •3.Pregnancy
- •4.The responsible clinician feels that the patient either needs low or high protein
- •5.Absolute contraindication to EN
- •6.Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.
- •7.Severe chronic liver disease (MELD-score >20) or acute fulminant hepatitis.
- •8.Metabolic disorders involving impaired nitrogen utilization
- •9.Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
- •10.Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
- •11.Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
- •12.Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
- •13.Intracranial or spinal process affecting motor function
- •14.Patients in hospital >5 days prior to ICU admission
研究者
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