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

Study Overview
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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.

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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Other: Tissue perfusion guided protocol
* Other: Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tissue perfusion guided protocol<br>Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy | Other: Tissue perfusion guided protocol<br>* A tissue perfusion guided protocol is used to guide hemodynamic therapy<br>|
| Other: Usual Care<br>Usual Care | Other: Usual Care<br>* Usual Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor Duration |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ failure free days |  | 28 days | 
| Catecholamine dose |  | 28 days | 
| Catecholamine related adverse events |  | 28 days | 
| ICU length of stay |  | 28 days |