NCT02428790已完成不适用
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Gastrointestinal transit time (GITT) [in days]
研究概览
简要总结
Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.
The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
- •or Stroke
- •or Anoxic brain injury
- •Ability to swallow the capsules used to assess GITT
- •Ability to give meaningful informed consent to participate in the study
排除标准
- •Major abdominal disorders
- •Severe acute comorbidity
- •Known cancer
- •Pregnancy
- •Known autonomic neuropathy
- •Other known neurological disorder
结局指标
主要结局
Gastrointestinal transit time (GITT) [in days]
时间窗: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
次要结局
- Association between heart rate variability (HRV) and GITT(During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.)
研究者
相似试验
撤回
不适用
Gastrointestinal Transit Time in Patients With Guillain-Barré SyndromeGuillain-Barre SyndromeConstipationNCT02459808University of Aarhus
已完成
不适用
Gastrointestinal Motility in Patients With Neuroendocrine TumorsNeuroendocrine TumorNCT00789841University of Aarhus13
Unknown
不适用
Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transitUlcerative ColitisNCT01752361University of Aarhus20
已完成
不适用
Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of ConsciousnessDisorder of ConsciousnessNCT04530968First Affiliated Hospital of Zhejiang University200
暂停
3 期
The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtientsBrain InjuriesNCT05008926University Hospital, Brest370