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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01296789
Enrollment
40
Registered
2011-02-15
Start date
2011-02-28
Completion date
2013-04-30
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

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.

Interventions

OTHERTissue perfusion guided protocol

A tissue perfusion guided protocol is used to guide hemodynamic therapy

OTHERUsual Care

Usual Care

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Vasopressor Duration28 days

Secondary

MeasureTime frame
Catecholamine dose28 days
Catecholamine related adverse events28 days
Organ failure free days28 days
ICU length of stay28 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026