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Clinical Trials/CTRI/2025/08/093881
CTRI/2025/08/093881Not yet recruitingNot Applicable

Bedside cerebrospinal fluid CSF analysis by urine reagent strips and comparison with traditional lab measurements

Not provided1 site in 1 country125 target enrollmentStarted: September 26, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
125
Locations
1
Primary Endpoint
The primary outcome of this study is to assess the accuracy of urine reagent strips in detecting cerebrospinal fluid (CSF) abnormalities, specifically protein, glucose, and leukocyte esterase, in comparison to traditional laboratory measurements. The study aims to determine the reliability of urine reagent strips as a tool for semi-quantitative CSF analysis.

Study Overview

Brief Summary

This study aims to evaluate the utility of urine reagent strips for bedside cerebrospinal fluid (CSF) analysis, comparing their accuracy with traditional laboratory measurements. In settings where access to advanced laboratory facilities is limited, rapid and reliable diagnostic tools are crucial. The study, conducted over a two-year period at AVBRH hospital in Maharashtra, focuses on neonatology and paediatrics patients undergoing CSF examination. The primary objective is to assess the accuracy of urine reagent strips in semi-quantitative analysis of CSF protein, glucose, and leukocyte esterase. Secondary objectives involve comparing strip values with laboratory measurements, studying the accuracy for different cutoff values, and determining the sensitivity and specificity for CSF protein, sugar, and cells. A sample size of 125 patients was calculated based on the sensitivity and specificity of the reagent strip method, considering a prevalence of meningitis, precision, and a confidence level of 95%. Ethical approval has been obtained, and the study will include patients diagnosed with CNS infection. The methodology encompasses CSF microscopy, biochemical analysis, and urine reagent strip tests. Statistical analyses will employ diagnostic accuracy measures and construct receiver operating curves to determine optimal cutoff levels. This study holds promise for providing a rapid and feasible approach to CSF analysis in resource-constrained healthcare settings.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 2.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary outcome of this study is to assess the accuracy of urine reagent strips in detecting cerebrospinal fluid (CSF) abnormalities, specifically protein, glucose, and leukocyte esterase, in comparison to traditional laboratory measurements. The study aims to determine the reliability of urine reagent strips as a tool for semi-quantitative CSF analysis.

Time Frame: Assessment will be done at 4 weeks

Secondary Outcomes

  • Secondary outcomes include evaluating the sensitivity and specificity of urine reagent strips for different cutoff values in detecting CSF protein, sugar, and cells. Diagnostic performance metrics, such as positive and negative predictive values, along with likelihood ratios, will be calculated to provide a comprehensive understanding of the utility of urine reagent strips in CSF examination. Additionally, the study will explore the optimal cutoff levels through the analysis of CSF protein, sugar, and neutrophil counts, using receiver operating characteristic (ROC) curves. Comparative assessments between urine reagent strip values and traditional laboratory measurements will be conducted, and an exploratory analysis will be carried out to understand the potential impact of rapid bedside assessment on patient prognosis and outcomes.(One day)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Shahzad Ahmad

Datta Meghe Institute of Higher Education and Research

Study Sites (1)

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