PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections
研究概览
简要总结
The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
- •Patients with acute isolated spinal fracture, lesion may include more than 1 segment
- •Legal age of the patient
- •Documented informed consent of the patient
排除标准
- •Non-traumatic spinal cord injury
- •Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
- •Neoplasia and/or antineoplastic therapy
- •Pregnancy, lactation
结局指标
主要结局
Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections
时间窗: At all study time-points for a period of 24hours.
Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients "at risk" for developing infections.
次要结局
未报告次要终点
研究者
Jan Schwab
Director of Spinal Cord Medicine
Ohio State University