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

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

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.

Study Overview

• Status: Terminated
• Conditions: Septic Shock
• Intervention / Treatment: Other: Usual Care; Other: Tissue perfusion guided 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Department of Intensive Care Medicine, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vasopressor Duration	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Jukka Takala, Department of Intensive Care Medicine, Bern University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 101/10