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Aneurysm, RupturedHCP-GlcNCT06486909

Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood

An observational study of Aneurysm, Ruptured and Hyperglycemia, run by Isabel Hostettler at 3 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to confirm the association of early increased glucose levels in cerebro-spinal fluid (CSF) and ventriculo-peritoneal-shunt (VPS)-dependency also evaluating the influence of blood glucose on VPS dependency in patients suffering from an aneurysmal subarachnoid haemorrhage (aSAH). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aneurysm, Ruptured, Hyperglycemia, Hydrocephalus
What is being tested?
Cerebrospinal Fluid (CSF) Sample and Blood Serum Sample
How many people
160 participants
Where
3 sitesSwitzerland
Study dates
26 Mar 2024to Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted with aneurysmal subarachnoid haemorrhage

Who may be able to join

  • 18 years old and older
  • Hospital admission due to an aneurysmal subarachnoid haemorrhage (radiological confirmation needed)

Who cannot join

  • Younger than 18 years old
  • Non-aneurysmal subarachnoid haemorrhage (eg. trauma, perimesencephalic subarachnoid haemorrhage, mycotic or flow-associated aneurysms)
  • Previous enrolment into the current study

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Isabel Hostettler, MD PhD contact

+41 71 494 97 40

isabel.hostettler@kssg.ch

Lauren Wiebe, BSN MSc contact

lauren.wiebe@kssg.ch

Switzerland3 sites, 3 recruiting
  • Cantonal Hospital Aarau

    Aarau, 5001

    Basil Grüter, MD, Basil.Grueter@ksa.ch

    Recruiting
  • University Hospital Basel

    Basel, 4031

    Michel Röthlisberger, MD, Michel.Roethlisberger@usb.ch

    Recruiting
  • Cantonal Hospital St Gallen

    Sankt Gallen, 9007

    Isabel Hostettler, MD PhD, +41 71 494 97 40, Isabel.hostettler@kssg.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Shunt-dependency After Aneurysmal Subarachnoid Haemorrhage - the Role of Early Hyperglycaemia in Cerebro-spinal Fluid and Blood

The goal of this study is to confirm the association of early increased glucose levels in cerebro-spinal fluid (CSF) and ventriculo-peritoneal-shunt (VPS)-dependency also evaluating the influence of blood glucose on VPS dependency in patients suffering from an aneurysmal subarachnoid haemorrhage (aSAH). The main questions we aim to answer are:

  • Is there an association of glucose levels on VPS dependency in patients requiring extra-ventricular-drain (EVD) placement for aSAH?
  • In addition, if there is, what is the influence the course of glucose levels has on VPS dependency?

Glucose levels in CSF and serum will be measured on admission, or in case of CSF, upon EVD placement. Glucose in CSF will then be measured every day until EVD removal together with serum glucose. Follow-up will be conducted in person after 3 and 6 months.

Read the detailed description

Aneurysmal SAH is a haemorrhage into the subarachnoid space associated with high mortality and morbidity. Several factors influence morbidity and therefore outcome after aSAH with HCP being one such factor. Hydrocephalus is a well-known complication after aSAH. It is thought to occur due to arachnoid adhesions as a reaction to the blood in the subarachnoid space, leading to impaired CSF absorption. Hydrocephalus is associated with an increased risk of poor clinical outcome, cognitive disturbance, and decreased functional status[3-5]. As such, HCP is associated with a significant increase in morbidity and mortality in aSAH patients and warrants treatment, preferably early. In acute HCP, diversion of CSF is conducted via insertion of an EVD. Due to the blood in the CSF, a permanent system, such as a VPS, is not inserted in the early stages as it would get blocked due to clots. If patients cannot be weaned from the EVD due to persisting HCP a VPS, is then inserted if the CSF is not too bloody anymore. Incidence of aSAH-associated HCP is up to 67%, of which about 50% end up needing a VPS. Several risk factors (ie. increased age, female sex, rebleeding, intraventricular haemorrhage, Fisher grade, and Hunt and Hess grade) have been reported. One factor, especially interesting due to its potential target as a treatment option, is hyperglycaemia. Hyperglycaemia after aSAH is common and most likely due to humeral activation including catecholamine release altering homeostasis. Previous studies have reported an association between hyperglycaemia and VPS dependency. The pathophysiological mechanism behind this potential association remains unclear but is likely due to it adhesions caused by hyperglycaemia and therefore reduction of CSF outflow potentially through higher viscosity. Inflammation, disruption of immune function and disruption of endothelial function might also play a role by decreasing reabsorption. The aim of this study is to evaluate the association of glucose levels in CSF, as well as serum (as CSF glucose is proportional to blood glucose), at prespecified time points and its association with VPS dependency in patients requiring EVD. In this step, timing of VPS insertion is going to be conducted as per our standard. Assessment of early (without trying out repeated weaning) versus late VPS insertion will only be evaluated once the association has been proven in our study.

Being tested
Cerebrospinal Fluid (CSF) Sample, Blood Serum Sample
Keywords
aneurysmal subarachnoid haemorrhage, hyperglycaemia, hydrocephalus, ventriculo-peritoneal shunt, extra-ventricular drain
Medical subject headings
Aneurysm, Ruptured, Hyperglycemia, Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cerebrospinal Fluid (CSF) SampleDiagnostic test

    Samples for glucose in CSF will be taken upon EVD/LD placement until EVD/LD removal (within the first 14 days).

  • Blood Serum SampleDiagnostic test

    Samples for glucose in blood serum will be completed every day, for the first 14 days.

Study groups in NCT06486909
Study groupRoleWhat they receive
aSAH PatientsPatients with an acute ruptured intracranial aneurysm.
Receives: Diagnostic Test: Cerebrospinal Fluid (CSF) Sample; Diagnostic Test: Blood Serum Sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventriculo-peritoneal shunt (VPS) dependency

    Glucose levels in patients requiring EVD/LD placement for aSAH and its influence on VPS dependency.

    Measured: 6 months

Secondary outcomes (1)
  1. Modified Ranking Scale (mRS)

    Modified Ranking Scale 0-6 where 0 means no symptoms and 6 death (adjusting for VPS dependency) in aSAH patients requiring EVD/LD placement

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start26 Mar 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06486909
Sponsor's protocol ID
2022-02108
Acronym
HCP-Glc
Status last verified
Mar 2026
First submitted
27 Jun 2024
Last updated
18 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysm, Ruptured and Hyperglycemia, run by Isabel Hostettler at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Isabel Hostettler, MD PhD (+41 71 494 97 40, isabel.hostettler@kssg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventriculo-peritoneal shunt (VPS) dependency (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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