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NCT Number: NCT06486909

Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital Aarau, Aarau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerebrospinal Fluid (CSF) Sample

Diagnostic Test

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

Blood Serum Sample

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Modified Ranking Scale (mRS)

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Hostettler, MD PhD

CONTACT

[email protected]

+41 71 494 97 40

Lauren Wiebe, BSN MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Isabel Hostettler

Other

Collaborators

  • Kantonsspital Aarau
  • University Hospital, Basel, Switzerland

Registry information

Official study title

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

Acronym: HCP-Glc

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 5, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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