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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tissue perfusion guided protocol

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

Group Type ACTIVE_COMPARATOR

Tissue perfusion guided protocol

Intervention Type OTHER

A tissue perfusion guided protocol is used to guide hemodynamic therapy

Usual Care

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual Care

Interventions

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Tissue perfusion guided protocol

A tissue perfusion guided protocol is used to guide hemodynamic therapy

Intervention Type OTHER

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No