To examine the effect of parasympathetic and sympathetic nervous system activity on the systemic innate immune response and the incidence of nosocomial infections in patients with vascular or traumatic brain injury. A second objective is to…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
nosocomial infection
Secondary outcome
heart rate variability, markers of sympathetic, inflammatory and coagulation
response, 28- and 60-day mortality, ventilator-free days, length of ICU/CMC
stay and hospital stay.
Background summary
Patients with vascular or traumatic brain injury often develop secondary
nosocomial infection, in particular in the first few days following the insult,
leading to enhanced morbidity and mortality. This phenomenon may be due to
immune suppression following brain injury.
Study objective
To examine the effect of parasympathetic and sympathetic nervous system
activity on the systemic innate immune response and the incidence of nosocomial
infections in patients with vascular or traumatic brain injury.
A second objective is to determine the mechanism of brain injury mediated
immunosuppression.
Study design
Two-site prospective observational case-control study
Study burden and risks
There is no potential benefit for the research participants. The risk to
incapacitated adults is no greater than that to brain injury patients able to
give consent, and the study specifically pertains to this group of more
severely brain injured patients. We expect the study to cause a minimum of
discomfort to participants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with ischemic or hemorrhagic cerebrovascular accident or patients with traumatic brain injury, requiring admission and monitoring on the Intensive Care Unti or Central Medium Care
Exclusion criteria
Moribund patients
Patients requiring an emergency thoracotomy
Known pregnancy;
Burns or inhalation injury;
Patients who received cardiopulmonary resuscitation with chest compressions (> 5 consecutive minutes) before ICU/CMC arrival
Patients with known do-not-resuscitate order prior to inclusion
Patients receiving immunosuppressive medication
Patients enrolled in a concurrent ongoing interventional, randomized clinical trial
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 | NL40155.018.12 |