Actively Recruiting
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P in Patients With Post-operative Meningitis
Led by Melike Cengiz · Updated on 2024-07-19
51
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on adult patients with suspected meningitis related to cerebrospinal fluid (CSF) drainage systems, particularly those followed in the intensive care unit. It aims to evaluate the usefulness of calcitonin gene-related peptide (CGRP) and substance P levels as biomarkers for diagnosing and monitoring treatment response in post-operative meningitis, a condition that can be difficult to diagnose accurately with current methods and carries high risks of mortality and morbidity. Patients included in the study will have blood and CSF samples collected at specific times: before meningitis symptoms appear, just before the first dose of antibiotics on the first day of symptoms, and after the last antibiotic dose on the third day. These samples will be tested for CGRP and substance P levels using the ELISA method, alongside routine clinical and laboratory tests. Clinical parameters such as consciousness level, fever, sepsis status, and organ failure will also be recorded, as well as imaging results and length of ICU stay. Throughout the study, researchers will monitor various factors including patient outcomes in the ICU, survival or mortality, laboratory and radiographic findings, and infection markers. The primary outcome focuses on diagnosis over 16 months, with prognosis as a secondary outcome measure. This observational study will follow participants from initial assessment through their ICU stay to collect comprehensive data on the role of these neuropeptides in meningitis.
CONDITIONS
Brief Title
Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and over
- Patients followed up in the intensive care unit with suspected meningitis
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to development of meningitis symptoms
Participants with suspected post-operative meningitis have blood and cerebrospinal fluid samples collected during routine clinical practice to analyze Calcitonin Gene-related Peptide and Substance P levels.
Samples taken at three key points: before meningitis symptoms, just before first antibiotic dose, and after last antibiotic dose on day 3
Duration - Up to 16 months
Participants are observed in the intensive care unit with clinical parameters recorded including consciousness level, fever response, organ failure, sepsis status, and ICU outcomes such as survival or mortality.
Trial Site Locations
Total: 1 location
1
Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Antalya, Turkey (Türkiye)
Actively Recruiting
Research Team
M
Melike Cengiz, MD,Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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