Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Septic Shock

Treatments: Other: Usual Care; Other: Tissue perfusion guided protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01296789

101/10

Details and patient eligibility

About

The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.

Full description

Background

Septic shock is a frequent and severe entity with a mortality of 55%. The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients.

For hemodynamic stabilization the SSC recommends as treatment goals a mean arterial blood pressure > 65mmHg (MAP), a central venous blood pressure of 8-12 mmHg, a mixed venous oxygen saturation >65%, a central venous oxygen saturation > 70% and a diuresis > 0.5 ml/kg/h (1). According to the SSC guidelines a MAP > 65 mmHg should be aimed because at this blood pressure level tissue perfusion is preserved. This is based on a study in ten septic shock patients where norepinephrine was titrated to three levels (65, 75 and 85 mmHg) and the authors concluded that parameters of tissue perfusion did not differ between the each level (2).

Objective

To evaluate if a hemodynamic protocol guided by parameters of tissue perfusion could reduce the duration of vasopressor treatment in septic shock patients.

Methods

Patients suffering from septic shock requiring vasopressor support are randomly assigned to a control group (usual care) and an intervention group (tissue perfusion guided protocol). In the intervention group parameters of tissue perfusion are used to guide hemodynamic therapy.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 2 or more SIRS criteria according to ACCP/SCCM definition
• Documented infection or strong suspicion of infection with adequate antibiotic treatment
• Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment

Exclusion Criteria

• Patients admitted with central nervous diseases
• ST elevation myocardial infarction
• Pulmonary embolism
• Out of hospital cardiac arrest patients
• Patients with therapy limitations
• Known pregnancy
• Inclusion in other interventional trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tissue perfusion guided protocol

Active Comparator group

Description:

Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy

Treatment:

Other: Tissue perfusion guided protocol

Usual Care

Other group

Description:

Usual Care

Treatment:

Other: Usual Care