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Procalcitonine Als marker van Liquor Drain INfecties


- candidate number17985
- NTR NumberNTR4619
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mei-2014
- Secondary IDsNL 47941.098.14 
- Public TitleProcalcitonine Als marker van Liquor Drain INfecties
- Scientific TitleProcalcitonin as marker for cerebrospinal fluid drain infections
- ACRONYMPALADIN
- hypothesisAbout 25% of patients who suffer from a subarachnoid hemorrhage or intraventricular hemorrhage have a vital indication for an external ventricular or lumbar drain to aleviate the intracranial pressure. About 5-10% of these patients develop a ventriculitis as a complication of this drain. Diagnosing an infection in this group of patients is difficult because the normal signs of infection (e.g. fever, neck stiffness) are already present due to the blood in the ventricles or for example a systemic infection. The difficulty in interprating the infection parameters leads to a delay in treatment or treatment without a proper indication. This results in increased morbidity as well as prolonged hospitalization, redundant drain replacement and needless antibiotic therapy. The concentration of procalcitonin in plasma is proven to be an adequate diagnostic tool for diagnosing a systemic bacterial infection. Therefore we hypothesize that intraventricular procalcitonin production is a valuable biomarker for a bacterial drain infection. We will collect some additional cerebrospinal fluid to preserve for testing of other parameters in the future.
- Healt Condition(s) or Problem(s) studiedDrain, Meningitis, Ventriculitis
- Inclusion criteriaPatients >18 years old with an external lumbar or ventricular drain
- Exclusion criteriaExpected death <24 hours
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jul-2014
- planned closingdate31-dec-2016
- Target number of participants250
- InterventionsThe PALADIN study is an observational study. In our hospital daily sampling of cerebrospinal fluid and serum is a routine procedure in patients with a ventricular or lumbar drain. There will be no additional sampling for this study.
- Primary outcomePresence of a bacterial drain infection
- Secondary outcome-Duration of hostpitalization
-Admission of antibiotica
-Drain replacement
-Mortality
-Modified Rankin Scal 3 months after drain placement
- Timepoints-Baseline
-3 Months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES K. Dorresteijn
- CONTACT for SCIENTIFIC QUERIES K. Dorresteijn
- Sponsor/Initiator Medical Center Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
Medical Center Haaglanden
- Publications
- Brief summaryThis study aims to increase the accuracy of diagnosing a cerebrospinal fluid drain infection. One of the parameters of interest is procalcitonin in cerebrospinal fluid. We will collect some additional cerebrospinal fluid to preserve for testing of other parameters in the future.
- Main changes (audit trail)
- RECORD29-mei-2014 - 30-jun-2014


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