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

Primary Purpose

Septic Shock

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tissue perfusion guided protocol
Usual Care
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Intensive Care Medicine, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Tissue perfusion guided protocol

Usual Care

Arm Description

Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy

Usual Care

Outcomes

Primary Outcome Measures

Vasopressor Duration

Secondary Outcome Measures

Organ failure free days
Catecholamine dose
Catecholamine related adverse events
ICU length of stay

Full Information

First Posted
February 14, 2011
Last Updated
July 27, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01296789
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Problems implementing the trial
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tissue perfusion guided protocol
Arm Type
Active Comparator
Arm Description
Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Tissue perfusion guided protocol
Intervention Description
A tissue perfusion guided protocol is used to guide hemodynamic therapy
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Vasopressor Duration
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Organ failure free days
Time Frame
28 days
Title
Catecholamine dose
Time Frame
28 days
Title
Catecholamine related adverse events
Time Frame
28 days
Title
ICU length of stay
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jukka Takala
Organizational Affiliation
Department of Intensive Care Medicine, Bern University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Intensive Care Medicine, Bern University Hospital
City
Bern
State/Province
Canton of Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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

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