Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Severe Sepsis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00484133
• Other study ID #: WO-06.068
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2007
• Last updated: January 17, 2008
• Start date: June 2007

Study information

• Verified date: January 2008
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: Rutger v Raalte, MD
• Phone: 0031205993007
• Email: R.vanRaalte[@]olvg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microcirculation
• Sepsis
• Severe Sepsis

Intervention

Drug:
• Dopamine

• dobutamine

• enoximone

• nitroglycerine

• noradrenaline

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis, intensive care	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis		72 hours	Yes
Secondary	Severity, decrease and duration of organ failure over the complete ICU stay		complete icu stay	No
Secondary	Duration of organ support		during ICU treatment	No
Secondary	ICU and hospital length of stay		hospital stay	No
Secondary	ICU and hospital mortality		hospital stay	No
Secondary	Inflammatory response measured by IL-6/IL-10		72 hours	No
Secondary	Plasma concentration of asymmetric dimethyl arginine (ADMA		72 hours	No