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CompletedNCT06090812Updated Apr 1, 2024

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

An observational study in Acute Brain Injury, Paroxysmal Sympathetic Hyperactivity and Volume Status, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Brain Injury
  • Paroxysmal Sympathetic Hyperactivity
  • Volume Status
  • Right Heart Function
  • Right Cardiogenic Pulmonary Edema
  • Glasgow Outcome Scale Extended
03

In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's enrollment of 30 is below the median of 118 across 57 observational studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • acute brain injury

    The included population was patients with acute brain injury, protected from acute cerebrovascular events, traumatic brain injury, and acute cerebral edema. Assessment of stress levels, Ultrasound evaluation of volume status, right heart function, and pulmonary edema.

    Other: Ultrasound evaluation

Interventions

  • OtherUltrasound evaluation

    Ultrasound evaluation of volume status, right heart function, and pulmonary edema.

06

What researchers measure

Primary outcomes

  1. Assessment of stress levels

    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.

    Time frame: Day 1, Day 3, Day 5

  2. Ultrasound evaluation of volume status

    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.

    Time frame: Day 1, Day 3, Day 5

  3. Ultrasound evaluation of right heart function

    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.

    Time frame: Day 1, Day 3, Day 5

07

Study locations

1 site
  • Wei Du
    Beijing, Beijing 100010, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06090812
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Oct 19, 2023
Start date
Jan 1, 2021
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022
Last update
Apr 1, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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