No registrations found.
ID
Source
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
SARS-CoV-2 RT-PCR of cerebrospinal fluid
Secondary outcome
- 8-week mortality
- Leukocyte count of the cerebrospinal fluid
- Serum Leukocyte count, C-reactive protein, Lactate dehydrogenase, D-Dimer
Background summary
Rationale: Acute respiratory failure in COVID-19 may be caused by neuroinvasion of SARS-CoV-2.
Objective: To investigate the prevalence of SARS-CoV-2 presence in the cerebrospinal fluid of patients with a proven SARS-CoV-2 infection and acute respiratory failure.
Study design: Pilot study
Study population: Adult (>18 years of age) COVID-19 patients admitted to the Zuyderland hospital in the Netherlands.
Intervention (if applicable): -
Main study parameters/endpoints: RT-PCR of SARS-CoV2 in the cerebrospinal fluid.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will be exposed to the complications and discomfort associated with diagnostic lumbar puncture, which is considered a low-risk procedure. As patients will be sedated during the procedure, they will not experience periprocedural discomfort. The study is considered group-related as uncovering the pathophysiology of acute respiratory distress in COVID-19 patients may be a starting point for research aimed at improving the prognosis of COVID-19 patients.
Study objective
SARS-CoV-2 is present in the cerebrospinal fluid of COVID-19 patients with acute respiratory failure
Study design
Follow-up after 8 weeks
Inclusion criteria
- At least 18 years of age
- Requires mechanical ventilation
- Proven SARS-CoV-2 infection
- Lumbar puncture possible within 48 hours of ICU admission
- Informed consent provided by either patient or legal representative
Exclusion criteria
- Contraindication for lumbar puncture
- Proven or suspected cerebrospinal fluid leak or other blood-brain barrier defects
- Any condition known to alter cerebrospinal fluid biochemistry
- Known or suspected cause for respiratory failure, other than COVID-19
- Any disease known for decreasing pulmonary capacity or compliance
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8526 |
| Other | METC Z : Z2020090 |