The aim of this study is to create a prognostic model enabling the clinician to predict the outcome of a septic episode. Furthermore, by getting more insight in the pathophysiologic proces of sepsis, we could discover new possible targets for future…
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
90-day mortality
Secondary outcome
-Multi organ dysfunction syndrome (MODS) according to Marshall criteria
increasing abnormalities in the following organ specific parameters:
PO2/FiO2 ratio (lung)
Serum creatinine (kidney)
Platelet count (clotting system)
Glasgow coma score (neurological)
Serum bilirubin (hepatic)
Pressure-adjusted heart rate (HR): (HR x (Central Venous Pressure/Mean
Arterial Pressure)) (heart)
-Etiology (bacterial and/or viral)
-CRP,CRP-complement complex
-Parameters of systemic inflammation (cytokines, chemokines, complement
activation, cell numbers and differentiates)
-Parameters of local inflammation (cytokines, chemokines, complement
activation, cell numbers and differentiates)
-Coagulation/fibrinolysis parameters (both systemic and local)
-Markers for cellular damage
-Demographic data, medical history and health condition prior to
hospitalization will be documented for all patients.
Background summary
Sepsis is a common entitiy on the intensive care and is an often lethal
disease. Sepsis is a disorder in which a pathogen triggers an systemic
inflammatory respons. During a septic episode a disproportionate immuneresponse
occurs in the patient possibly leading to dysfunction of multiple organs (multi
organ dysfunction syndrome (MODS)). In many cases the pulmonary compartment is
targeted by the host's own immunesystem resulting in acute lung injury (ALI) or
acute respiratory distress syndrome (ARDS). Investigating sepsis is extremely
difficult due to the heterogenous character of sepsis with it's multiplcity in
etiology and the complex immunesystem responding as effector. In this study we
try by means of a multi-approach strategy to gain more insight in the
pathophysiologic proces of sepsis.
Study objective
The aim of this study is to create a prognostic model enabling the clinician to
predict the outcome of a septic episode. Furthermore, by getting more insight
in the pathophysiologic proces of sepsis, we could discover new possible
targets for future therapeutic interventions.
Study design
A longitudinal study in which 1067 septic, 500 non-infectious SIRS patients and
500 healthy age, gender and chronic co morbidity matched volunteers are
included. The patients are on the ICU of the Academic Medical Centre in
Amsterdam (AMC). In the septic patients blood will be collected three times a
day for seven consecutive days to analyse the patients systemic immune status.
Furthermore, a non-directed broncho-alveolar lavage will be performed in
mechanically ventilated patients on day 1, 2, 4 and 7 to determine the
immunestatus of the pulmonary compartment. Also, a nose-/throat swab will be
performed on day 1 and 4 for viral diagnostics.
In the SIRS group the same diagnostics are performed, but only once a day.
The healthy control group will be subjected to a single blood draw of 12ml.
Study burden and risks
Patients will experience a minimal burden by participating in this study. Blood
required for analysis will be collected through an already placed arterial
line. The non-directed broncho-alveolar lavages in this study are seen as a
standardisation of routine handlings of patient care.
Patients are not subjected to any additional risks by participating in this
study.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age: 18 years and older
Presence of an arterial line;Sepsis group: Patients admitted to the intensive care with sepsis, or patients developing sepsis during their stay on the intensive care.;SIRS patients: Critically ill patients who score positive on at least two SIRS criteria who do not suffer from sepsis and have an expected ICU stay of more than 24 hours.;Healthy volunteers: All healthy individuals without any recent febrile or infectious illness (within 2 weeks). Individuals capable of giving written informed consent.
Exclusion criteria
No informed consent;Patients receiving more than 24 hours of antibiotic treatment for a suspected infection prior to ICU admission.;Sepsis group: Previous participation in this study.;SIRS group: Previous participation in this study.;Healthy volunteers: Previous participation in this study.
A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrolment, including inflammatory diseases.
A recent febrile illness (within 2 weeks).
Recent use of anti-inflammatory medication (within 2 weeks).
Subject using tobacco and/or illicit drug products.
Current use of hormone therapy or current pregnancy.
Limited accessibility of a vein in the left or right arm.
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 | NL34294.018.10 |