In previous studies we have identified specific receptor and surface protein expression profiles on neutrophils. Some of these profiles point at partially refractory neutrophils. In the current NERTHUS study we have seen that circulating neutrophils…
ID
Source
Brief title
Condition
- Other condition
- Immune disorders NEC
- Bacterial infectious disorders
Synonym
Health condition
Trauma en acute post-operatieve patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary variables:
- Degree of inactivity of neutrophils
Primary outcome:
- Development of inflammatory-induced complications (sepsis/septic
shock/(multiple) organ failure)
(According to the SIRS/Sepsis criteria)
Secondary outcome
Secundary variables:
- Normalization of neutrophil receptor profile
- Percentage of cells in specific populations of neutrophils.
Secundary outcome:
- Development of inflammatory-induced complications (sepsis/septic
shock/(multiple) organ failure)
- Severity of illness during the intensive care period
(According to disease severity on admission: APACHE II Score)
(According to the maximal SOFA score during admission)
Background summary
Multiple organ failure due to the presence of sepsis is an important cause of
death in intensive care patients. Neutrophils play an important role in the
defence mechanisms against bacteria. Dysfunction of this component of the
innate immune system can lead to a paralysis of the immune system, which can
lead to sepsis. How this dysfunction of neutrophils develops and in which
timeframe is unknown.
Study objective
In previous studies we have identified specific receptor and surface protein
expression profiles on neutrophils. Some of these profiles point at partially
refractory neutrophils.
In the current NERTHUS study we have seen that circulating neutrophils are less
responsive to inflammatory stimuli. During the first 12 hours after injury, the
responsiveness of neutrophils is considerably lower in patients developping
septic complications compared to those who do not.
The aim of this study is to validate the correlation between neutrophil
unresponsiveness and the development of inflammatory-induced complications.
Study design
Immediately after admission (within 16 hours) a blood sample is taken.
Thereafter, bloodsamples will be taken on day 5 and 6 of admission. The blood
will be analyzed on the presence of neutrophils. These neutrophils are analyzed
for their degree of activation and the presence of specific surface proteins.
The APACHE II Score is determined on admission. Furthermore, the SOFA score and
MODS score are calculated on a daily basis. This can be done by variables which
are determined daily on the intensive care.
The presence of sepsis is classified by the SIRS/Sepsis criteria.
Study burden and risks
There is no additional risks involved for the patient. The blood taken on a
daily basis is drawn from the arterial line. The study protocol stops when the
patient leaves the intensive care.
Heidelberglaan 100
3508 GA Utrecht
Nederland
Heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1) Patients admitted to the intensive care unit
2) After sugery or major trauma
3) Age above 18
4) Expected stay > 2 days
Exclusion criteria
Immunological compromised - e.g. patients treated with steroids and/or cytostatic drugs
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 | NL11380.041.06 |