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

Acute Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06090812
• Other study ID #: 2022-PUMCH-A-266
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: October 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ß-blocker use; 10) comorbid spinal cord injury; 11) death or discharge from hospital within 5 days of hospitalization.

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Paroxysmal Sympathetic Hyperactivity
• Pulmonary Edema
• Volume Status
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
China	Wei Du	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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