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

Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P in Patients With Post-operative Meningitis

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.

Study Overview

• Status: Recruiting
• Conditions: Meningitis; Diagnosis; Prognosis
• Intervention / Treatment: Other: CGRP level

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 patient's 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 (survival/mortality) will also be recorded for use in the analysis.

• Study Type: Observational
• Enrollment (Estimated): 51

Contacts and Locations

• Study Contact: Name: Melike Cengiz, MD,Professor; Phone Number: +902422496231; Email: melikecengiz@yahoo.com

Study Locations

• Turkey
  • Antalya, Turkey
    • Recruiting
    • Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
    • Contact: Ulku Arslan Yildiz, MD; Phone Number: +902422496231; Email: drulkuarslan@gmail.com
    • Contact: melike cengiz, Professor; Phone Number: +902422496231; Email: melikecengiz@yahoo.com
    • Sub-Investigator: Ulku Arslan yildiz, MD
    • Principal Investigator: Oguzhan Arslan, MD
    • Principal Investigator: Gul Ozbey, MD
    • Sub-Investigator: Sebahat Ozdem, MD
    • Sub-Investigator: Melike Cengiz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Postoperative meningitis patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postoperative meningitis mortality; Patients with postoperative meningitis and mortality in the intensive care unit.	Other: CGRP level; CGRP and substance P levels will be analysed by ELISA method in CSF and blood materials.; Other Names: Substans P level
Postoperative meningitis survival; Patients who developed postoperative meningitis and were discharged from the intensive care unit.	Other: CGRP level; CGRP and substance P levels will be analysed by ELISA method in CSF and blood materials.; Other Names: Substans P level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis	The role of CGRP and substance P levels in blood and CSF samples in the diagnosis of postoperative meningitis	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognosis	The role of CGRP and substance P levels in blood and CSF samples in the evaluation of postoperative meningitis treatment response and prediction of patient prognosis	16 months

Collaborators and Investigators

• Sponsor: Melike Cengiz

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Substance P; Calcitonin gene-related peptide; Postoperative meningitis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuroinflammatory Diseases; Meningitis
• Other Study ID Numbers: Akdeniz U. Faculty Medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No