Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510751
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P in Patients With Post-operative Meningitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In cases of meningitis caused by external ventricular catheters EVDs which are the most commonly placed intracranial catheters that can lead to central nervous system infection through contaminationcolonisation the diagnosis may not be differentiated by either clinical signs and symptoms or conventional cerebrospinal fluid CSF tests Therefore due to the limitations in diagnosis and prognostic prediction of EVD-induced meningitis and the high mortalitymorbidity rates of the disease markers with high sensitivity and specificity in post-operative meningitis are needed Calcitonin gene-related peptide CGRP a neuropeptide has been shown to increase when C or Aδ sensory fibres are damaged or in the presence of inflammation in tissues adjacent to the fibres CGRP is localised in nociceptive nerve terminals together with another neuropeptide substance P which has similar biological effects There are very few studies investigating how CGRP levels in CSF and serum change in bacterial meningitis Although it is thought that nociception and neuroimmune interactions affect meningeal antibacterial host defence that nociceptors signal via CGRP to meningeal immune cells during infection and that this neuroimmune axis exacerbates bacterial meningitis by weakening host defence it is not yet clear how CGRP and substance P levels affect disease prognosis This study will evaluate the utility of CGRP and substance P levels as biomarkers to assess diagnosis and treatment response in patients with post-operative meningitis followed in the intensive care unit
Detailed Description:
Adult patients 18 years of age and older with suspected CSF drainage system-related meningitis who are followed up in the Intensive Care Unit will be included in the study Blood and CSF samples taken during routine clinical practice before the development of meningitis symptoms just before the first dose of antibiotherapy on the first day of meningitis symptoms after the last dose of antibiotherapy on the 3rd day of antibiotherapy CSF smear CSF culture and CSF direct examination CSF biochemistry parameters will be studied and the materials will be taken into tubes containing aprotinin proteinase inhibitor to study CGRP and substance P levels in blood and CSF materials to be destroyed CGRP and substance P levels will be analysed by ELISA method Among the clinical parameters the patients state of consciousness Glasgow coma scale fever response vasoactive drug requirement organ failure sepsis and septic shock status SOFA and APACHE II scores will be recorded Laboratory parameters available in routine clinical practice haemogram biochemical tests microbiological growths infection parameters radiographic examination findings computed brain tomography brain magnetic resonance imaging intensive care unit length of stay and intensive care unit outcomes survivalmortality will also be recorded for use in the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None