Clinical trial NCT01296789: Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients
Official title: Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Conventional Hemodynamic Protocol in Septic Shock Patients: a Prospective, Randomised, Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Septic Shock
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vasopressor Duration
timeFrame: 28 days
Secondary outcomes:
measure: Organ failure free days
timeFrame: 28 days
measure: Catecholamine dose
timeFrame: 28 days
measure: Catecholamine related adverse events
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care Medicine, Bern University Hospital
state: Canton of Bern
Study officials:
affiliation: Department of Intensive Care Medicine, Bern University Hospital
name: Jukka Takala
role: STUDY_CHAIR
References: