Brain Damage, General Anesthetics Toxicity, Hydrocephalus
Conditions
Keywords
Hydrocephalus, Brain biomarkers, Neurofilament Light Chain, General Anesthesia
Brief summary
Neurofilament Light Chain Protein (NfL) has been found by many studies as a sensitive biomarker of neuronal damage from several reasons, e.g. neurodegenerative diseases (Alzheimer's disease, Multiple Sclerosis, etc.), inflamation (HIV) or trauma. Its role as biomarker thus offers a possibility to predict and manage diseases associated with neuronal damage. Therefore our aim is to investigate the changes in level of NfL in hydrocephalus and to find its role in management of treatment in hydrocephalus.
Interventions
DIAGNOSTIC_TESTLumbar puncture
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
DIAGNOSTIC_TESTExternal lumbar drainage
External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement
DIAGNOSTIC_TESTLumbar infusion test
Diagnostic test accompanying the first lumbar puncture made as i diagnostic test of hydrocephalus. Based on infusion of saline by 90 mL per hour with measurement of CSF pressure each 1 minute and then count of so-called Rout (index).
Surgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally).
PROCEDUREGeneral Anesthesia
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
PROCEDUREPrechamber puncture
Puncture of prechamber (place behind the ear under the skin) by thin needle and aspiration of 5 mL of CSF (5 days, 1 month a 2 months after surgery)
PROCEDUREBlood sampling #1
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
PROCEDUREBlood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
PROCEDUREBlood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
PROCEDUREBlood sampling #4 and #5
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group)
Sponsors
University Hospital Hradec Kralove
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In group A: * Patients with diagnosed communicating hydrocephalus * MMSE \> 10 points * Absence of any structural laesion on MRI or CT * Accepted Informed consent * In group B: * MMSE \> 10 points * Absence of any structural laesion on MRI or CT * Accepted Informed consent * Elective spinal surgery without affecting dural sac and the spinal cord * Surgery shorter than 120 minutes of lasting the general anesthesia
Exclusion criteria
* Non-communicating hydrocephalus * Structural laesion on MRI or CT (tumour, contusion, aneurysm) * MMSE \< 10 points * Life-expectancy shorter than 1 year * Pre-existing other type of demetia (m. Alzheimer, vascular dementia) * Surgery lasting more than 120 minutes * Blood loss more than 500 ml * Opening of dural sac (liquororhea) * Adverse events during general anestesia: MAP\<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study |
| Number of changes in valve settings | 3 months after surgery | To investigate the number of changes in valve settings according the patient's clinical state based on clinical examination, CT examination or telemetrically measured CSF pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between NfL level and patient's clinical state | 3 months after surgery | To investigate in group A the correlation between the level of NfL get from CSF and blood sampling and observation in changes in patient's clinical state measured by mini-mental state examination (MMSE), 5-meter-walking test and patient's self-assessment questionare |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence of general anesthesia on the level of NfL | 24 hours before procedure (surgery) and 24 hours and 5 days after surgery | In group B investigate the level of NfL 24 hours before surgery and 24 hours (blood sampling #2) and 5 days after surgery (blood sampling #3) and comparison with standardized NfL level based on literature. Looking for the influence of general anesthesia on brain damage caused and the prepair in predefined time frame. |
Countries
Czechia
Outcome results
None listed