Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis

Onze Lieve Vrouwe Gasthuis

Status and phase: Unknown; Phase 4

Conditions: Severe Sepsis; Microcirculation

Treatments: Drug: noradrenaline; Drug: Dopamine; Drug: enoximone; Drug: dobutamine; Drug: nitroglycerine

Study type: Interventional

Funder types: Other

Identifiers

NCT00484133

WO-06.068

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)