跳至主要内容
临床试验/NCT06090812
NCT06090812已完成不适用

Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Ultrasound evaluation of right heart function

研究概览

简要总结

In this study, we investigated the clinical variability in paroxysmal sympathetic hyperactivity in patients with acute brain injury and examined the prognostic value of the Paroxysmal Sympathetic Hyperactivity Assessment Measure (PSH-AM) in relation to Doppler ultrasound assessment of volume status, right heart function, and pulmonary edema. Thirty patients with ABI were prospectively enrolled. A correlation analysis between the PSH-AM score and related clinical indicators was performed using Pearson's or Spearman's correlation coefficient. Receiver operating characteristic curves were used to assess the prediction of the 6-month Glasgow Outcome Scale Extended score for neurorehabilitation prognosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only adult patients (>18 years of age) were included. The other inclusion criteria were 1) definite cerebrovascular accident or craniocerebral injury (a clear change in consciousness or suggestive imaging); 2) the ability to undergo ultrasound to obtain information on volume status and cardiac and pulmonary monitoring; and 3) fulfilment of the measurement conditions.

排除标准

  • The exclusion criteria were 1) a history of cardiovascular disease, such as coronary artery disease, heart failure, or atrial fibrillation; 2) presence of severe valvular disease or an EF of <30%; 3) chronic lung disease; 4) chronic liver failure or renal insufficiency; 5) comorbid malignant neoplasm or acute/chronic infectious disease prior to craniocerebral injury; 6) pregnancy or breastfeeding; 7) history of psychiatric disorders; 8) history of drug abuse or alcohol misuse; 9) history of β-blocker use; 10) comorbid spinal cord injury; 11) death or discharge from hospital within 5 days of hospitalization.

结局指标

主要结局

Ultrasound evaluation of right heart function

时间窗: Day 1, Day 3, Day 5

In the apical four-chamber view, a TDI sample volume was placed on the RV free wall at a distance of 1 cm from the tricuspid annulus.

Ultrasound evaluation of volume status

时间窗: Day 1, Day 3, Day 5

The cardiac ultrasound probe was placed under the xiphoid process, and the probe was moved from the upper abdominal position to the standard four-chamber view of the heart under the xiphoid process, where the right ventricle is first seen. The probe was rotated downward and toward the spine, with the directional marker pointing toward the patient's head, showing the inferior vena cava (IVC) entering the right atrium and the hepatic vein converging into the IVC. The IVC diameter was measured 2 cm from the entrance of the right atrium, and the ultrasound images were frozen at the end of expiration and at the end of inspiration to measure the maximum IVC diameter. Simultaneous measurement of central venous pressure (CVP) was obtained.

Assessment of stress levels

时间窗: Day 1, Day 3, Day 5

The PSH-AM score is the sum of the CFS and DLT scores, and assesses the likelihood of a diagnosis of PSH. A score of \<8 means that PSH is unlikely, 8-16 suggests that PSH is likely, and ≥17 suggests that PSH is highly likely.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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