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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01296789
First received: February 14, 2011
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Septic Shock
 Other: Tissue perfusion guided protocol
Other: Usual Care

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Vasopressor Duration [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 128
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Usual Care
Usual Care
 Other: Usual Care
Usual Care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296789

Locations
Switzerland
Department of Intensive Care Medicine, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Jukka Takala Department of Intensive Care Medicine, Bern University Hospital
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01296789     History of Changes
Other Study ID Numbers: 101/10
Study First Received: February 14, 2011
Last Updated: March 28, 2012
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 16, 2013