NCT02716532已完成不适用
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support
研究概览
简要总结
This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).
This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.
The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Comatose patients (defined by an initial Glasgow Coma Scale (GCS) < 9) following sTBI or aSAH.
- •Female or male, aged >
- •Abnormal head CT-Scan (contusions, hematoma).
- •Intracranial monitoring with CMD, [PbtO2] and [ICP] probes as part of standard of care.
- •Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
- •Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study
排除标准
- •Signs of brain death or expected brain death within 48h.
- •Pregnancy.
- •Hemodynamic instability (circulatory shock, requiring vasopressors).
- •Renal or liver insufficiency .
- •Chronic intestinal disease.
- •Patients requiring parenteral nutrition .
- •Currently participating or having participated in another clinical trial during the month preceding the study
研究组 & 干预措施
Peptamen AF
Other
over 7 days
干预措施: Peptamen AF (Dietary Supplement)
结局指标
主要结局
Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support
时间窗: Over 7 days
次要结局
- Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients(After at least 2 consecutive days of stable enteral nutrition)
- Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients(Over 7 days (not necessarily at stable EN).)
- As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients(Over 7 days)
- Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care(Over 7 days)
- To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients(Over 7 days)
- Evaluation of the time to reach two days of stable nutrition in all patients(Over 7 days)
研究者
研究点 (1)
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