Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06486909
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood
Sponsor:
Isabel Hostettler
Organization:
Cantonal Hospital of St Gallen
Study Overview
Official Title:
Shunt-dependency After Aneurysmal Subarachnoid Haemorrhage - the Role of Early Hyperglycaemia in Cerebro-spinal Fluid and Blood
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCP-Glc
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
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 status3-5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None