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.
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.
Lauren Wiebe, BSN MSc contact
Switzerland3 sites, 3 recruiting
- 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
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.
- Conditions
- Aneurysm, Ruptured, Hyperglycemia, Hydrocephalus
- 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 group | Role | What they receive |
|---|---|---|
| aSAH Patients | Patients 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.
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)
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.
- First posted5 Jul 2024
- Study start26 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, RupturedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Isabel Hostettler
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Isabel Hostettler, Cantonal Hospital of St. Gallen
- Investigators
- Isabel Hostettler, MD PhD, Principal investigator, Cantonal Hospital of St. Gallen
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shunt-dependency After Aneurysmal Subarachnoid Haemorrhage - the Role of Early Hyperglycaemia in Cerebro-spinal Fluid and Blood
- ClinicalTrials.gov ID
- NCT06486909
- Acronym / sponsor ID
- HCP-Glc / 2022-02108
- Conditions
- Aneurysm, Ruptured, Hyperglycemia, Hydrocephalus
- Keywords
- aneurysmal subarachnoid haemorrhage, hyperglycaemia, hydrocephalus, ventriculo-peritoneal shunt, extra-ventricular drain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Isabel HostettlerUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau, University Hospital, Basel, Switzerland
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aSAH Patients | – | Diagnostic Test: Cerebrospinal Fluid (CSF) Sample, Diagnostic Test: Blood Serum SamplePatients with an acute ruptured intracranial aneurysm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with aneurysmal subarachnoid haemorrhage
Key inclusion criteria (2 listed)
- 18 years old and older
- Hospital admission due to an aneurysmal subarachnoid haemorrhage (radiological confirmation needed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrospinal Fluid (CSF) SampleSamples for glucose in CSF will be taken upon EVD/LD placement until EVD/LD removal (within the first 14 days). | Diagnostic test | aSAH Patients |
| Blood Serum SampleSamples for glucose in blood serum will be completed every day, for the first 14 days. | Diagnostic test | aSAH Patients |
Primary outcome
Ventriculo-peritoneal shunt (VPS) dependency
Time frame: 6 months
Glucose levels in patients requiring EVD/LD placement for aSAH and its influence on VPS dependency.
1 secondary outcome
Modified Ranking Scale (mRS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Aneurysm, Ruptured
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
RecruitingObservational study
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
Active, not recruitingObservational study
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Wiebe, BSN MSc contact
Isabel Hostettler, MD PhD principal investigator
Cantonal Hospital of St. Gallen
3 sites in 1 country: see every site and its status.
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.