Study Stopped
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Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 28, 2015
July 1, 2015
2.2 years
February 14, 2011
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Vasopressor Duration
28 days
Secondary Outcomes (4)
Organ failure free days
28 days
Catecholamine dose
28 days
Catecholamine related adverse events
28 days
ICU length of stay
28 days
Study Arms (2)
Tissue perfusion guided protocol
ACTIVE COMPARATORActive comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy
Usual Care
OTHERUsual Care
Interventions
A tissue perfusion guided protocol is used to guide hemodynamic therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients admitted with central nervous diseases
- ST elevation myocardial infarction
- Pulmonary embolism
- Out of hospital cardiac arrest patients
- Patients with therapy limitations
- Known pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Intensive Care Medicine, Bern University Hospital
Bern, Canton of Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jukka Takala
Department of Intensive Care Medicine, Bern University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
July 28, 2015
Record last verified: 2015-07