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

NCT ID: NCT06486909

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2027-09-30

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.

Conditions

Aneurysm, Ruptured; Hyperglycemia; Hydrocephalus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

aSAH Patients

Patients with an acute ruptured intracranial aneurysm.

Cerebrospinal Fluid (CSF) Sample

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Cerebrospinal Fluid (CSF) Sample

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

Intervention Type: DIAGNOSTIC_TEST

Blood Serum Sample

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Aarau

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Isabel Hostettler

OTHER

Sponsor Role: lead

Responsible Party

Isabel Hostettler

PD Dr. med. Isabel Charlotte Hostettler, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabel Hostettler, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Locations

Cantonal Hospital Aarau

Aarau, , Switzerland

Site Status: RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Cantonal Hospital St Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Isabel Hostettler, MD PhD

Role: CONTACT

isabel.hostettler@kssg.ch

+41 71 494 97 40

Lauren Wiebe, BSN MSc

Role: CONTACT

lauren.wiebe@kssg.ch

Facility Contacts

Basil Grüter, MD

Role: primary

Basil.Grueter@ksa.ch

Michel Röthlisberger, MD

Role: primary

Michel.Roethlisberger@usb.ch

Isabel Hostettler, MD PhD

Role: primary

Isabel.hostettler@kssg.ch

+41 71 494 97 40

Other Identifiers

2022-02108

Identifier Type: -

Identifier Source: org_study_id