Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Phase 4

• Conditions: Severe Sepsis; Microcirculation

• Registration Number: NCT00484133
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-08
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-17
• Last Update Posted: 2008-01-22
• Primary Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ICU and hospital length of stay	hospital stay
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 mortality	hospital stay
Plasma concentration of asymmetric dimethyl arginine (ADMA	72 hours
Inflammatory response measured by IL-6/IL-10	72 hours

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis, intensive care; 🇳🇱 Amsterdam, Netherlands