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 Details — Status: Terminated

Administrative data

• NCT number: NCT01296789
• Other study ID #: 101/10
• Status: Terminated
• Phase: N/A
• First received: February 14, 2011
• Last updated: July 27, 2015
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Tissue perfusion guided protocol
A tissue perfusion guided protocol is used to guide hemodynamic therapy
• Usual Care
Usual Care

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine, Bern University Hospital	Bern	Canton of Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasopressor Duration		28 days	No
Secondary	Organ failure free days		28 days	No
Secondary	Catecholamine dose		28 days	No
Secondary	Catecholamine related adverse events		28 days	No
Secondary	ICU length of stay		28 days	No