Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P

NCT06510751 | Recruiting

• 1 other identifier: Akdeniz U. Faculty Medicine
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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 contamination/colonisation, 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 mortality/morbidity 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.

Conditions

Meningitis; Diagnosis; Prognosis

Keywords

Postoperative meningitis; Calcitonin gene-related peptide; Substance P

Outcome Measures

Primary Outcomes (1)

• Diagnosis

  The role of CGRP and substance P levels in blood and CSF samples in the diagnosis of postoperative meningitis

  16 months

Secondary Outcomes (1)

• Prognosis

  16 months

Study Arms (2)

Postoperative meningitis mortality

Patients with postoperative meningitis and mortality in the intensive care unit.

Other: CGRP level

Postoperative meningitis survival

Patients who developed postoperative meningitis and were discharged from the intensive care unit.

Other: CGRP level

Interventions

CGRP level OTHER

CGRP and substance P levels will be analysed by ELISA method in CSF and blood materials.

Also known as: Substans P level

Postoperative meningitis mortality; Postoperative meningitis survival

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postoperative meningitis patients

You may qualify if:

• Patients aged 18 years and over
• Patients followed up in the intensive care unit with suspected meningitis

You may not qualify if:

• Patients under 18 years of age
• Patients with suspected meningitis in the intensive care unit who have not undergone neurosurgical operation and do not have CSF drainage catheter

Sponsors & Collaborators

• Melike Cengiz: lead

Study Sites (1)

Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

Antalya, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid Serum plasma

MeSH Terms

Conditions

Meningitis; Disease

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Melike Cengiz, MD,Professor

CONTACT

+902422496231; melikecengiz@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,Professor Doctor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: March 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 30, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)