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Monitoring Band for Encephalic Involvement in Liver Diseases

Non-invasive method for Monitoring Intracranial Pressure in the evaluation of Hepatic Encephalopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-5dym7yh
Enrollment
Unknown
Registered
2023-04-05
Start date
2023-04-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Interventions

specific cause of liver disease
and comorbidities. Regarding the disease, the following will be recorded: type of liver disease
This is a prospective-analytical study of the diagnostic test type. Control group: 30 patients with liver disease without hepatic encephalopathy. Experimental group: 30 liver disease patients with pre
heart rate variability will be recorded with the Polar H10 heart rate monitor for 20 minutes
and the participants identification data and exposures described in the electronic medical record will be collected. Participants' descriptive data collected from the medical record will include: medi
full name
age
sex
previous CT scan with evidence of cerebral edema
whether there was invasive intracranial pressure monitoring
invasive intracranial pressure at the time of insertion
post-insertion maximal invasive intracranial pressure
monitoring days
occurrence of hemorrhage. Regarding the treatment, it will be collected: if there was a liver transplant
hyperosmolar treatment
and others. Regarding the laboratory tests of the participants, they will be tabulated, if any: maximum INR
and serum ammonia (minimum, maximum, average). Regarding the state of the participants liver disease, it will be reported: neurological symptoms classification according to neurological score. About t

Sponsors

Faculdade de Medicina de São José do Rio Preto - Famerp - SP
Lead Sponsor
Brain4Care
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with acute liver disease; subjects with chronic liver disease; subjects with exacerbation of chronic liver disease

Exclusion criteria

Exclusion criteria: Refusal by the subjects or their guardians to participate in the study; subjects with healthy liver

Design outcomes

Primary

MeasureTime frame
Using the Brain4Care band, it is expected to find a correlation between non-invasive intracranial pressure data and a clinical picture compatible with hepatic encephalopathy

Secondary

MeasureTime frame
Using the Polar H10 cardiac monitor and the BWS system, it is expected to find a correlation between non-invasive intracranial pressure data, heart rate variability and the clinical status of hepatic encephalopathy

Countries

Brazil

Contacts

Public ContactMoacir de Godoy

Faculdade de Medicina de São José do Rio Preto - Famerp - SP

moacir.godoy@edu.famerp.br+551732015927

Outcome results

None listed

Source: REBEC (via WHO ICTRP)