1. To estimate the additional value of early MRI monitoring for the prediction of neurological outcome of comatose patients after cardiac arrest. 2. To gain insight in the pathophysiology of PAE by functional MRI measures and by associating MRI…
ID
Source
Brief title
Condition
- Heart failures
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is neurological outcome, defined as the score on
the Cerebral Performance Category (CPC) at six months, dichotomized as good
(CPC 1-2 = no or moderate neurological disability) or poor (CPC 3-5 = severe
disability, coma, or death)
Secondary outcome
Secondary outcome measures include cognitive functioning, depression, and
quality of life at one year, as well as histopathological damage of brain
tissue of non-survivors.
Background summary
30-70% of comatose patients admitted to the intensive care unit (ICU) after
cardiac arrest never regain consciousness as a result of post anoxic
encephalopathy (PAE). Early identification of patients without potential for
recovery of brain functioning may prevent inappropriate continuation of medical
treatment and improve communication between doctors and patients. However,
current diagnostic and prognostic measures can identify only 20-50% of the
patients with irreversible brain damage, precluding cerebral recovery and
awakening. Also, the pathophysiology of brain damage is largely unclear. New
magnetic resonance imaging (MRI) sequences hold potential to substantially
improve outcome prediction.
Study objective
1. To estimate the additional value of early MRI monitoring for the prediction
of neurological outcome of comatose patients after cardiac arrest.
2. To gain insight in the pathophysiology of PAE by functional MRI measures and
by associating MRI findings with histopathological studies of brain tissue
obtained from non-survivors.
Study design
Prospective cohort study
Intervention: In addition to standard treatments, patients will undergo MRI
scanning of the brain at day 3, 7, and three months after cardiac arrest. A
subgroup of patients will be scanned within 24 hours after cardiac arrest, to
assess feasibility and to gain more insight in the evolution of brain damage in
PAE. Survivors will be followed for one year. Outcome measurements will focus
on disabilities, quality of life, and depression.
Study burden and risks
MRI is a daily used imaging technique with no known short term or long term
harm. Transport of comatose patients from the ICU to the radiology department
introduces a risk in case of hemodynamic or pulmonary instability. To minimize
this risk, only patients that are considered stable will be transported to
undergo MRI. A physician and ICU nurse will accompany the patient at all times
during transport and scanning. All materials necessary for continuous
monitoring and treatment, together with materials for emergency situations, are
stored in a mobile trolley. The medical team can act immediately in case of
complications. The MR signal will not interfere with patient treatment and will
cause no damage to the patients. Participation in this trial will not change,
delay, or interfere with standard treatment, nor will it change the ICU or
hospital admission time. Herewith, risk of participation is considered
negligible
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Comatose, defined as Glasgow Coma Score <= 8
Age >= 18 years
Cardiac arrest with a presumed cardiac cause of the arrest or caused by
lungembolism
Admission on ICU
Exclusion criteria
Pregnancy
Life expectancy < 24 hours
Absence of written informed consent (by a legal representative)
Any known progressive brain illness, such as a brain tumor or neurodegenerative
disease.
Known contra-indication for MRI
Preexistente afhankelijkheid (CPC3-4)
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 |
---|---|
ClinicalTrials.gov | NCT03308305 |
CCMO | NL62151.091.17 |