41
Participants
Start Date
December 7, 2023
Primary Completion Date
September 27, 2025
Study Completion Date
September 27, 2025
Lumbar puncture
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and CSF sampling (sample 1 in NfL level measurement)
External lumbar drainage
External lumbar drainage placement for assessing responsivity of external derivation of CSF. It is test of responsivity to ventriculo-peritoneal shunt placement
Lumbar 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).
Ventriculo-peritoneal shunt placement
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).
General Anesthesia
Standardized combinated general anesthesia with combination of i.v. and inhalated drugs according the protocol. Given by anesthesiologist.
Prechamber 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)
Blood sampling #1
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling #2
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling #3
Blood sampling to get level of NfL from standarized percutaneous vein puncture by thin needle 5 days after surgery
Blood 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)
University Hospital Hradec Kralove, Hradec Králové
University Hospital Hradec Kralove
OTHER