Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients
|ClinicalTrials.gov Identifier: NCT01296789|
Recruitment Status : Terminated (Problems implementing the trial)
First Posted : February 15, 2011
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Other: Tissue perfusion guided protocol Other: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- Vasopressor Duration [ Time Frame: 28 days ]
- Organ failure free days [ Time Frame: 28 days ]
- Catecholamine dose [ Time Frame: 28 days ]
- Catecholamine related adverse events [ Time Frame: 28 days ]
- ICU length of stay [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|