•What is the prognostic value of CO2 reactivity compared to standard TCD measurements to predict the occurrence of DCI in patients with SAH?•Does magnesium therapy change CO2 reactivity after SAH?
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Occurrence of delayed cerebral ischemia, defined by a persisting clinical
deterioration (i.e. new focal deficit, decrease in consciousness, or both) with
no evidence for rebleeding or hydrocephalus on CT and no other medical causes,
such as infections or metabolic disturbances, and with or without hypodensity
on CT.
2. Occurrence of a disturbed CO2R test
Secondary outcome
Occurrence of radiographic vasospasm and perfusion parameters on CT-P
Background summary
An important complication after subarachnoid hemorrhage (SAH) is delayed
cerebral ischemia (DCI), that is responsible for poor outcome (death or
dependency on activities for daily life) in one third of patients. Currently,
the additional prophylactic benefit of magnesium sulphate therapy is studied in
a randomized controlled clinical trial (MASH-II, METC nr NL17943.041.07).
Accurate prediction of DCI is however still not possible. The prognostic value
of vasospam on trancranial doppler (TCD) is diappointing to predict the
occurrence of DCI. Besides vasospasm, a disturbed cerebral autoregulation is
also indicated as a contributing factor in the pathophysiology of DCI. A
non-invasive technique to determine cerebral reactivity is measuring the
response of CO2 inhalation with TCD. There are indications that CO2 reactivity
(CO2R) has a better predictive value for DCI than standard TCD measurements.
This has not yet been studied in a larger patient population and optimal
cut-off points remain unclear. There are also indications that magnesium
therapy reduces the amount of TCD detected vasospam, but the effect on cerebral
vasoreactivity is unknown. Prediction and a better understanding of DCI is
important to allow for better therapautic oppurtunities in the future.
Study objective
•What is the prognostic value of CO2 reactivity compared to standard TCD
measurements to predict the occurrence of DCI in patients with SAH?
•Does magnesium therapy change CO2 reactivity after SAH?
Study design
This is a prospective diagnostic cohort study and will be imbedded in the
DECIDE study (METC nr NL17943.041.07), that studies the pathogenesis of DCI
with CT-perfusion parameters.
Study burden and risks
TCD is a non-invasive and painless procedure that is part of daily standard
patient care in many centers worldwide. The CO2R test performed during the TCD
will take approximately 10 minutes. Side effects associated with CO2 inhalation
are minimal and transient. Side effects can be agitation, anxiety, dizziness or
headache. When a patient reports such a side effect the CO2 inhalation will be
stopped immediately. Temporarily increased intracranial pressures have also
been described, but always normalized after cessation of the CO2 inhalation. No
adverse neurological or other medical complications due to the test were
described. We do not monitor intracranial pressure routinely, as this is a very
invasive procedure.
As this is a diagnostic study, no direct benefits are expected for the
participating patients. The extra monitoring of the patients due to this study
could lead in some cases to the early detection of abnormalities and a suited
intervention. For future patients, the benefit is a better understanding,
prediction and therefore treatment of DCI.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Aneurysmal subarachnoid hemorrhage
Inclusion within 3 days after the hemorrhage
Aged 18 years or older
Informed consent obtained
Exclusion criteria
•Impaired renal function (Creatinine > 200 µmol/l)
•Diabetes Mellitus
•Acute general reactions to or contra-indications for the admission contrast CT-scan
•Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23336.041.08 |