Severe Sepsis, Microcirculation
Conditions
Keywords
sepsis, severe sepsis, microcirculation, Orthogonal polarisation spectral
Brief summary
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
Detailed description
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the standard treatment using predefined pressure goals versus a microcirculation guided therapy.
Interventions
Sponsors
Onze Lieve Vrouwe Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria * intention to provide full intensive care treatment for at least 72 hours and * written informed consent to be obtained from patient or next of kin.
Exclusion criteria
* haematologic malignancy * metastatic malignancy * AIDS with CD4 \< 50 cells/mm3 * liver cirrhosis Child Pugh B & C * pregnancy * post resuscitation with GCS \< 8 of 15 and treatment with induced hypothermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| ICU and hospital length of stay | hospital stay |
| ICU and hospital mortality | hospital stay |
| Duration of organ support | during ICU treatment |
| Plasma concentration of asymmetric dimethyl arginine (ADMA | 72 hours |
| Severity, decrease and duration of organ failure over the complete ICU stay | complete icu stay |
| Inflammatory response measured by IL-6/IL-10 | 72 hours |
Countries
Netherlands
Contacts
Primary ContactRutger v Raalte, MD
Backup ContactPeter vd Voort, MD
Outcome results
None listed