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

Septic Shock Clinical Trial

Official title:
Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Conventional Hemodynamic Protocol in Septic Shock Patients: a Prospective, Randomised, Controlled Study

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01296789
Study type Interventional
Source University Hospital Inselspital, Berne
Contact
Status Terminated
Phase N/A
Start date February 2011
Completion date April 2013
View Details
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