The general aim of this study is to investigate the course of cognitive functioning during the first year after an OHCA. In order to find correlations which might suggest treatable causalities, cognitive functioning will be linked to parameters…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Neurological disorders NEC
- Disturbances in thinking and perception
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the cognitive impairments i.e. the
neuropsychological parameters for impairments in perception, language, memory,
attention, reasoning and executive functioning 2, 6 and 12 months after an
OHCA.
Secondary outcome
The secondary parameters are the delay time to BLS, length of ICU-stay,
duration of mechanical ventilation, severity of delirium and lowest registered
blood pressure and arterial saturation. Demographic parameters (age, gender,
level of education), the affective state and PTSD are covariates.
Background summary
An out of hospital cardiac arrest (OHCA) is common (30-40 pers/100.000/y in the
Netherlands alone) and has a total mortality risk of 75%. Patients who have
been successfully resuscitated after a cardiac arrest are at risk to experience
long-term cognitive, emotional and/or physical impairments. E.g., between 30
and 50 % of survivors experience cognitive deficits for up to several years
post-discharge. The majority of studies investigate the cognitive functioning
and the long-term impairment, but it is less known to what degree cognitive
functioning may recover over time. In this study we will measure cognitive
recovery of OHCA survivors and explore if there are causalities related to
parameters of the ICU stay
Study objective
The general aim of this study is to investigate the course of cognitive
functioning during the first year after an OHCA. In order to find correlations
which might suggest treatable causalities, cognitive functioning will be linked
to parameters routinely collected shortly before and during the ICU stay, such
as delay time to BLS, length of ICU-stay, duration of mechanical ventilation,
severity of delirium and lowest registered blood pressure and arterial
saturation. We expect that the parameters routinely collected shortly before
and during ICU stay will be correlated negatively to (the course of) cognitive
functioning in the first year after an OHCA.
Study design
This is a one-year follow-up prospective cohort-study.
The participants will be assessed with:
1. Neuropsychological tests
2. Questionnaires in Castor (online questionnaire)
The neuropsychological tests and the questionnaires in Castor will be
administered three times during the first year after an OHCA; 2-3 months (T1),
6 months (T2) and 12 months (T3). The moment of neuropsychological assessment
will have a range of -7/+7 days. The Questionnaires have to be filled in from
one weeks before the neuropsychological testing to ultimately at the same day
in addition to the assessment (see figure 3.1 timeline).
For each participant in this study clinical and demographic characteristics
will be prospectively collected in a database:
- Demographic: Age, gender, level of education.
- Parameters routinely collected shortly before and during the ICU stay; like
length delay to BLS, length of ICU stay, length of mechanical ventilation,
severity of delirium and lowest registered blood pressure and arterial
saturation.
- Medical history.
- Type and dose of medication.
Duration:
The study will collect participants for 2,5 years after the first participant
is included. All participants will be followed for 1 year. The maximum duration
of the study will be 3,5 years (2,5 years of including, 1 year follow-up).
Study burden and risks
Patients who are included in the study will be asked to visit the hospital 3
times for a 60-75 minutes neuropsychological testing and 30 minutes of
questionnaires. In some cases this might be physically or psychologically
strenuous. Reliving memories might distress some participants. However,
according to experience based practice, the possibility to talk about their
clinical period is often experienced as releasing.
The outcomes of neuropsychological assessment can be stressing especially when
cognitive impairments are found. However, once serious problems are found, this
will give the opportunity to refer to specialists who can treat these problems
who would otherwise gone unnoticed or treated or dealt with in a less adequate
or even worsening way.
A small financial compensation for travelling costs is provided for.
Tegelseweg 210
Venlo 5912BL
NL
Tegelseweg 210
Venlo 5912BL
NL
Listed location countries
Age
Inclusion criteria
Patients of 18-85 years.
Resuscitated out of hospital.
Discharged from the hospital within 2 months after resuscitation.
First cardiac arrest.
Ability to visit the hospital at 2-6 and 12 months.
Exclusion criteria
In hospital resuscitation.
Futile care in case mortality is expected within 12 months.
Unable to communicate, read or understand information read aloud for them.
Acquired brain injury, neurodegenerative disease or brain surgery in the
medical history.
Native language other than Dutch.
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 | NL71281.015.19 |