No registrations found.
ID
Source
Brief title
Health condition
drain related meningitis or ventriculitis
drain gerelateerde meningitis of ventriculitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of a bacterial drain infection
Secondary outcome
-Duration of hostpitalization
-Admission of antibiotica
-Drain replacement
-Mortality
-Modified Rankin Scal 3 months after drain placement
Background summary
This 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.
Study objective
About 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.
Study design
-Baseline
-3 Months
Intervention
The 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.
Lijnbaan 32, 2512 VA Den Haag
K. Dorresteijn
Den Haag
The Netherlands
070-330200
k.dorresteijn@mchaaglanden.nl
Lijnbaan 32, 2512 VA Den Haag
K. Dorresteijn
Den Haag
The Netherlands
070-330200
k.dorresteijn@mchaaglanden.nl
Inclusion criteria
Patients >18 years old with an external lumbar or ventricular drain
Exclusion criteria
Expected death <24 hours
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4486 |
NTR-old | NTR4619 |
CCMO | NL47941.098.14 |