Comparison of Different CSF Sampling Sites on External Ventricular Drains

Cerebrospinal Fluid Clinical Trial

— CSF3S  

Official title:

Comparison of Different CSF Sampling Sites on External Ventricular Drains

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254353
• Other study ID #: S65845
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Philippe De Vloo, prof.dr.
• Phone: 016 344290
• Email: neurochirurgie[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the current study is to evaluate the difference between proximal and distal CSF sampling. If the characteristics of distally and proximally sampled CSF are similar or correlate well, it may be possible to only sample CSF distally in the future, thereby avoiding the risks mentioned above.

Description:

Insertion of an external ventricular drain (EVD) is a common neurosurgical procedure, for example in patients with intracranial bleeding, head trauma of tumours. The aim of an external ventricular drain is either to drain cerebrospinal fluid (CSF) or to measure intracranial pressure. In patients with external ventricular drains, it is a common practice in many centres, including UZ Leuven, to routinely sample CSF two or three times a week. The following tests are routinely performed: protein level, glucose level, lactate level, white cell count, red cell count, and cultures. Gram stain is performed in case white blood cell count exceeds 5 cells/mm³. This regular sampling (1) permits early detection of ventriculitis, which may be rather asymptomatic, especially in sedated patients,and (2) may guide neurosurgeons to the ideal timeframe to either taper the external ventricular drainage, or replace it by a ventriculoperitoneal shunt.

A typical external ventricular drainage system consists of a ventricular catheter, which is nowadays usually impregnated with antibiotics (e.g. Codman Bactiseal - coated with clindamycin and rifampicin), an extension tube, a drip chamber, and a collection bag. Multiple three-way taps and access ports along its course allow for CSF sampling (or injection of therapeutics, such as tissue plasminogen activator, or saline to flush the catheter in case of blockage).

From a practical perspective, CSF sampling from the external ventricular drain is possible at all of these three-way taps and access ports. Broadly, one may sample CSF as proximally (close to the ventricle) as possible (e.g. by using the access port), or distally (at the level of the drip chamber, e.g. by using the three-way tap between the drip chamber and the collection bag). There is no consistency in for CSF collection site amongst different institutions. Traditionally, in UZ Leuven, we have been sampling CSF proximally until now.

The main theoretical advantage of proximal sampling is that actively aspirated "fresh" CSF close to the ventricle likely closely resembles the true characteristics of our study object, i.e. intraventricular CSF. Nevertheless, this approach is not without risk. First, it requires to directly access the sterile inside of the extension tube. This inherently comes with a risk of iatrogenic infection. Secondly, by aspirating the external ventricular catheter, the neurosurgeon may induce an iatrogenic haemorrhage in the brain parenchyma or the ventricle, and/or direct trauma to the brain parenchyma, as in suboptimally positioned catheters or small ventricles, white matter or choroid plexus may be aspirated along with CSF. Because of the risk of iatrogenic infections, haemorrhage or trauma, it is our institutional policy that CSF sampling from external ventricular drains is performed by neurosurgeons only. This also poses practical problems and may delay sampling, especially in patients who are not admitted to neurosurgical wards (e.g. paediatric cases).

From a theoretical perspective, distal CSF sampling, at the level of the drip chamber, has multiple advantages. First, the risk of iatrogenic infections induced by CSF sampling is likely to be lower, as there is no direct contact between the CSF in the drip chamber and the intraventricular CSF. Secondly, there is no risk of inducing haemorrhages or brain trauma, as no "active" aspiration is required for CSF sampling. Hence, distal CSF sampling can perhaps also be carried out by physicians from other fields than neurosurgery, or by trained nurses. However, theoretically, it is possible that the characteristics of CSF sampled distally do not sufficiently resemble those of intraventricular CSF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with an EVD in place regardless of the underlying pathology.

• Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject.

When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.

• Males and females of all ages, including children and pregnant females

Exclusion Criteria:

• Patients in whom the removal of the drain is planned within 48 hours, before routine sampling, will be excluded.

Related Conditions & MeSH terms

• Cerebrospinal Fluid

Intervention

Procedure:
• Analyses of proximal and distal samples
Evaluate the difference between proximal and distal CSF samples

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the CSF white cell count at day 1-4 and day 5-9 when comparing both sampling methods	The aim of the current study is to evaluate the difference between proximal and distal CSF sampling.	Day 1-4 and day 5-9 after placement of EVD
Secondary	White cell count correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Gram stain correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Culture correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Protein correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Glucose correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Lactate correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Red cell count correlation for all the available time points		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	Absolute difference between white blood cell count, protein, glucose, lactate, and red blood cell count		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)
Secondary	AEs likely related to CSF sampling, irrespective of the method (new or increased haemorrhage, infection)		Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)