Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Conventional Hemodynamic Protocol in Septic Shock Patients: a Prospective, Randomised, Controlled Study|
- Vasopressor Duration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Organ failure free days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Catecholamine dose [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Catecholamine related adverse events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- ICU length of stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
Other: Usual Care
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).
To evaluate if a hemodynamic protocol guided by parameters of tissue perfusion could reduce the duration of vasopressor treatment in septic shock patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296789
|Department of Intensive Care Medicine, Bern University Hospital|
|Bern, Canton of Bern, Switzerland, 3010|
|Study Chair:||Jukka Takala||Department of Intensive Care Medicine, Bern University Hospital|