·Establish the sublingual Microvascular Flow Index (MFI) in trauma patients and the relationship between shock class, as defined by the American College of Surgeons and MFI.·Demonstrate correlation between shock-room MFI measurements and mortality…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circulatoire shock bij trauma patienten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MFI in trauma patients stratified by shock class, as defined by the American
College of Surgeons.
Secondary outcome
Predictive value of the MFI at T1 and T2 for mortality and MOF in comparison to
Base Excess, Lactate and Shock Class.
Heart rate; systolic, mean and diastolic blood pressure; temperature;
respiratory rate.
Arterial blood gases; lactate; total blood count; electrolytes; pre-hospital
administration of vaso-active drugs, use of IV fluids (transient/non
responders). SOFA score, ISS
Background summary
Tissue dysoxia in critically ill patients is regarded as the major factor
leading to multisystem organ Failure (MOF) and higher mortality rate. Early
correction of tissue dysoxia may prevent progression to organ failure and
provide maximal benefit in terms of outcome. Therefore, early detection and
correction of tissue dysoxia is of great importance.
The traditional systemic hemodynamic and oxygenization variables are relatively
nonspecific and have limited roles in detecting persistent global tissue
dysoxia and may be normal in early stages of circulatory shock. Visualization
of microcirculation is a promising method for early detection of tissue
dysoxia. The microcirculatory disturbance occurs earlier than usual indicators
in shock. Additionally, microcirculatory alterations correlate to the severity
of shock and these alterations predict patient outcome better than traditional
markers.
Study objective
·Establish the sublingual Microvascular Flow Index (MFI) in trauma patients and
the relationship between shock class, as defined by the American College of
Surgeons and MFI.
·Demonstrate correlation between shock-room MFI measurements and mortality and
occurrence of MOF.
·Compare the predictive value of the MFI for mortality and MOF to conventional
resuscitation endpoints.
Study design
Prospective, non randomised, descriptive observational study.
Study burden and risks
Measurements can only be done after informed consent is obtained from the
patient or a legal representative. Verbal informed consent will be documented
by a witness. As soon as a patient is capable, written informed consent is
obtained.The risks of the 2 SDF measurements, comparable to oral temperature
measurement, are negligible. Therefore we consider use in patients with
impaired consciousness acceptable, especially since our study population is
very likely to suffer from impaired consciousness. The measurements will be
performed by a separate investigator, in order not to interfere with normal
ATLS-trauma care procedures. T1 laboratory results can be taken from the
standard blood samples taken from trauma patients. The T2 blood samples are
usually taken, but might in selected cases warrant an extra (arterial) blood
gas puncture. With each arterial blood gas sample taken, there*s a risk of
getting a haematoma. Systemic hemodynamic and oxygenization variables will be
measured as part of the normal evaluation of trauma patients. Outcome data will
be derived from patient files.
There is no direct benefit for the participant.
Postbus 22660
1100DD Amsterdam
Nederland
Postbus 22660
1100DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Trauma patients admitted to the shock-room of the emergency department of the Academic Medical Center, Amsterdam. These patients either meet the criteria of high energy trauma, or are otherwise suspected to have potentially life threatening injuries
Exclusion criteria
Younger than 18. No informed consent
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 | NL12142.018.06 |