Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Sponsor

Onze Lieve Vrouwe Gasthuis (Other)

Overall Status

Unknown status

CT.gov ID

NCT00484133

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis Microcirculation	Drug: Dopamine Drug: dobutamine Drug: enoximone Drug: nitroglycerine Drug: noradrenaline	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis [72 hours]

Secondary Outcome Measures

Severity, decrease and duration of organ failure over the complete ICU stay [complete icu stay]
Duration of organ support [during ICU treatment]
ICU and hospital length of stay [hospital stay]
ICU and hospital mortality [hospital stay]
Inflammatory response measured by IL-6/IL-10 [72 hours]
Plasma concentration of asymmetric dimethyl arginine (ADMA [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.