This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. By…
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiological outcome at 12-24 months follow-up: MRI abnormalities, focussing on
vascular abnormalities and olfactory tractus (3T MRI), and glymphatics and the
brainstem (7T MRI). Neurological outcome: residual neurological symptoms
(including smell/taste) and functional status at follow-up. Clinical outcome:
severity of disease scores, (serial) factors of hypercoagulability and
inflammation during ICU admission, neurological and cardiovascular
(arterial/venous) complications during hospital admission.
Secondary outcome
Neuropsychological outcome: global deficits in cognitive and neurological
functioning, objective changes in or loss of smell/taste and residual signs of
inflammation and hypercoagulopathy at follow-up.
Background summary
Brain injury is one of the complications in COVID-19 intensive care unit (ICU)
survivors, though the precise underlying mechanism is unclear. It is likely
caused by a combination of prolonged hypoxia, a massive systemic inflammatory
response, direct infection of the brain and small vessel vasculitis in
combination with widespread hypercoagulopathy and thrombosis. Using novel MRI
techniques, blood-brain barrier (BBB) permeability, as well as other
microstructural and microvascular properties of the brain tissue, will be
assessed non-invasively in COVID-19 ICU survivors approximately one year after
ICU admission and compared to serial clinical and laboratory measurements of
hypercoagulation and inflammation during the (ICU) admission. Moreover,
measures from the COVID-19 ICU survivors will be compared to an ICU control
group (without COVID-19) to gain insight into how specific the observed
abnormalities are to the Sars-CoV-2 virus or if these are also found in ICU
patients without COVID-19.
Study objective
This study aims to relate factors of hypercoagulability, inflammation or
general illness itself (all during ICU admission) to microstructural and
microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in
COVID-19 ICU survivors. By gaining more insight into the pathogenesis of brain
injury, the treatment of COVID-19 patients in the acute phase might be
improved.
Study design
Mono-center follow-up cohort study with measurements at 12-24 months post
hospital discharge. The main measurements include MRI scans, primarily focusing
on microstructural and microvascular abnormalities in the brain, and
(previously collected) parameters of hypercoagulability and inflammation during
ICU admission.
Study burden and risks
Patients will undergo an MRI scan (3T) and optionally a second MRI scan (7T) of
approximately 60 minutes each. The 3T scan will include intravenous
gadolinium-based contrast administration. Risks concerning contrast agent
administration will be negligible, as patients with an impaired renal function
(eGFR< 30 ml/min) are excluded from the study. For the 7T scan use of the
contrast agent is not required. The 7T scan will lead to insights, additional
to the 3T scan, in possible effects of a severe COVID-19 infection on the
brainstem and the glymphatic system.
Additional burden of approximately 1.5 hour consists of a short
neuropsychological test examination and two short questionnaires of cognitive,
neurological olfaction and functional status, smell and taste testing and one
venepuncture for blood collection (29ml) and infusion line for contrast agent
administration.
Patients will not benefit directly from participation in this study. However,
to learn more about the neurological sequelae of a severe COVID-19 infection
(with focus on inflammation and hypercoagulation markers), it is necessary to
perform high quality brain imaging in ICU survivors.
P. DeBeyelaan 25
Maastricht 6229 HX
NL
P. DeBeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
COVID-19 ICU survivors:
- Proven COVID-19 infection for which they were admitted to ICU for at least 3
days
- Included in the MaastrICCht cohort (a large database of serial measurements
collected during ICU stay from patients with COVID-19 admitted to the ICU in
het Maastricht University Medical Centre+; METC 2020-1565/3 00 523)
- Age >= 18 years
- Informed consent
- Sufficient command of the Dutch language to follow test instructions and
understand the information letter, informed consent, and questionnaires
ICU survivors:
- Admission to the intensive care unit at the Maastricht UMC+ for at least 3
days
- Reason for ICU admission: severe infection (bacterial, viral, fungal) with
respiratory insufficiency
- If tested for COVID-19 on ICU, negative PCR test result; if not tested for
COVID-19 on ICU, no suspicion for COVID-19 positive infection
- Age >= 18 years
- Informed consent
- Sufficient command of the Dutch language to follow test instructions and
understand the information letter, informed consent, and questionnaires
Exclusion criteria
COVID-19 ICU survivors:
- Objective cognitive impairments before the hospital admission for the
COVID-19 infection
- An unexpected incident leading to severe neurological damage after hospital
discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Physical inability to travel to one of the locations (e.g., bedridden
patients)
ICU survivors:
- Positive COVID-19 PCR test during ICU admission
- Objective cognitive impairments before the ICU admission
- An unexpected incident leading to severe neurological damage after hospital
discharge (such as stroke or traumatic brain injury)
- Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy and tattoos in the head/neck region)
- Unwillingness to be informed about clinical relevant (abnormal) MRI-findings
- Physical inability to travel to one of the locations (e.g., bedridden
patients).
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 | NL79868.068.21 |