Clinical trial NCT00484133: Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Sepsis
Microcirculation
Keywords: sepsis
severe sepsis
microcirculation
Orthogonal polarisation spectral
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2007-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
timeFrame: 72 hours
Secondary outcomes:
measure: Severity, decrease and duration of organ failure over the complete ICU stay
timeFrame: complete icu stay
measure: Duration of organ support
timeFrame: during ICU treatment
measure: ICU and hospital length of stay
timeFrame: hospital stay
measure: ICU and hospital mortality
timeFrame: hospital stay
measure: Inflammatory response measured by IL-6/IL-10
timeFrame: 72 hours
measure: Plasma concentration of asymmetric dimethyl arginine (ADMA
timeFrame: 72 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis, intensive care
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis, intensive care unit
name: Rutger v Raalte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.