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

Not Applicable

Terminated

• Conditions: Septic Shock
• Interventions: Other: Tissue perfusion guided protocol; Other: Usual Care

• Registration Number: NCT01296789
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed 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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue perfusion guided protocol	Tissue perfusion guided protocol	Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy
Usual Care	Usual Care	Usual Care

Primary Outcome Measures

Name	Time	Method
Vasopressor Duration	28 days

Secondary Outcome Measures

Name	Time	Method
Catecholamine dose	28 days
Organ failure free days	28 days
Catecholamine related adverse events	28 days
ICU length of stay	28 days

Trial Locations

Locations (1)

Department of Intensive Care Medicine, Bern University Hospital; 🇨🇭 Bern, Canton of Bern, Switzerland