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

NCT06090812 | Completed

• 1 other identifier: 2022-PUMCH-A-266
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Day 1, Day 3, Day 5

• 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.

  Day 1, Day 3, Day 5

• 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.

  Day 1, Day 3, Day 5

Study Arms (1)

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

Ultrasound evaluation OTHER

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

acute brain injury

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Wei Du

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)