Clinical trial NCT06090812: Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis
Official title: Initial Volume Status in Patients With Acute Brain Injury is Associated With Neurological Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Brain Injury
Paroxysmal Sympathetic Hyperactivity
Volume Status
Right Heart Function
Right Cardiogenic Pulmonary Edema
Glasgow Outcome Scale Extended
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only adult patients (\>18 years of age) were included. The other inclusion criteria were a definite cerebrovascular accident or craniocerebral injury (a clear change in consciousness or suggestive imaging); the ability to undergo an ultrasound to obtain information on volume status and cardiac and pulmonary monitoring; and fulfillment of the measurement conditions.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of stress levels
timeFrame: Day 1, Day 3, Day 5
measure: Ultrasound evaluation of volume status
timeFrame: Day 1, Day 3, Day 5
measure: Ultrasound evaluation of right heart function
timeFrame: Day 1, Day 3, Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei Du
state: Beijing
Study officials:
References: