EUCTR2016-003557-15-GB进行中（未招募）1 期
A Study to Investigate the Effect of ß-Hydroxy-ß-Methylbutyrate (HMB) on Skeletal Muscle Wasting in Early Critical Illness. - HMB-IC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- •Inclusion criteria are
- •(i) =18 years old
- •(ii) Due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care
- •(iii) Receiving mechanical ventilation and likely to continue this for more than 48 hours
- •(iv) Likely to remain on the ICU for >7 days
- •(v) Likely to survive intensive care admission.
- •(vi) Admitted to recruiting ICU <24 hours from hospital admission and referring ICU ? 7 days from hospital admission
- •(vii) Agreement obtained from legal representative
- •(viii) Able to comply with protocol and study procedures
- •(ix) No known allergy to IMP or any of its excipients
- •Participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective Chief Investigators.
- •Since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement.
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •(i) Pregnancy or breast feeding
- •(ii) Active disseminated malignancy (diagnosed)
- •(iii) Bilateral lower limb amputees
- •(iv) Non-ambulant or acute unilateral lower limb amputees
- •(v) Patients with a primary neuromyopathy
- •(vi) Patients entered into trials of interventions which would affect muscle mass
- •(vii) Patients assessed as requiring sole parenteral nutrition
- •(viii) Admission to ICU within the previous 3 months
- •(ix) Any reason excluding ultrasound measurement being performed
- •(ix) Insufficient understanding of the trial by the legal representative
- •(xi) Intolerance to lactose and/or milk protein allergy
研究者
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