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

NCT06486909 | Recruiting

• 1 other identifier: 2022-02108
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Aneurysm, Ruptured; Hyperglycemia; Hydrocephalus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ventriculo-peritoneal shunt (VPS) dependency

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

  6 months

Secondary Outcomes (1)

• Modified Ranking Scale (mRS)

  6 months

Study Arms (1)

aSAH Patients

Patients with an acute ruptured intracranial aneurysm.

Diagnostic Test: Cerebrospinal Fluid (CSF) Sample; Diagnostic Test: Blood Serum Sample

Interventions

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).

aSAH Patients

Blood Serum Sample DIAGNOSTIC_TEST

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

aSAH Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with aneurysmal subarachnoid haemorrhage

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isabel Hostettler: lead
• Kantonsspital Aarau: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (3)

Cantonal Hospital Aarau

Aarau, 5001, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Cantonal Hospital St Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebral spinal fluid (CSF) and blood serum samples.

MeSH Terms

Conditions

Aneurysm, Ruptured; Hyperglycemia; Hydrocephalus

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Isabel Hostettler, MD PhD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Hostettler, MD PhD

CONTACT

+41 71 494 97 40; isabel.hostettler@kssg.ch

Lauren Wiebe, BSN MSc

CONTACT

lauren.wiebe@kssg.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Isabel Charlotte Hostettler, PhD

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CH (3)