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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06486909
Acronym
HCP-Glc
Enrollment
160
Registered
2024-07-05
Start date
2024-03-26
Completion date
2028-09-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Ruptured, Hyperglycemia, Hydrocephalus

Keywords

aneurysmal subarachnoid haemorrhage, hyperglycaemia, hydrocephalus, ventriculo-peritoneal shunt, extra-ventricular drain

Brief 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). 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.

Interventions

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

DIAGNOSTIC_TESTBlood Serum Sample

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

Sponsors

Isabel Hostettler
Lead SponsorOTHER
Kantonsspital Aarau
CollaboratorOTHER
University Hospital, Basel, Switzerland
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Ventriculo-peritoneal shunt (VPS) dependency6 monthsGlucose levels in patients requiring EVD/LD placement for aSAH and its influence on VPS dependency.

Secondary

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

Countries

Switzerland

Contacts

CONTACTIsabel Hostettler, MD PhD
isabel.hostettler@kssg.ch+41 71 494 97 40
CONTACTLauren Wiebe, BSN MSc
lauren.wiebe@kssg.ch
PRINCIPAL_INVESTIGATORIsabel Hostettler, MD PhD

Cantonal Hospital of St. Gallen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026