- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01877798
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy
June 13, 2013 updated by: Peking Union Medical College Hospital
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Severe Sepsis and Septic Shock Therapy
Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen saturation (ScvO2) in the treatment of severe sepsis and septic shock.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Peking Union Medical College Hospital critical care medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- severe sepsis and septic shock patients
Exclusion Criteria:
- <18 years old
- pregnant and breast-feed woman
- AMI
- cerebral hemorrhage
- contraindication for central venous catheter or arterial catheter;
- brainstem death
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: △PCO2/Ca-vO2
△PCO2/Ca-vO2 directed group
|
|
|
Experimental: ScvO2
ScvO2 directed group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
mortality
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
June 12, 2013
First Submitted That Met QC Criteria
June 13, 2013
First Posted (Estimate)
June 14, 2013
Study Record Updates
Last Update Posted (Estimate)
June 14, 2013
Last Update Submitted That Met QC Criteria
June 13, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCSS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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