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Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
volume resuscitation, vasoactive drug
Sponsored by
Peking Union Medical College Hospital
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:

  • 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

Sites / Locations

  • Peking Union Medical College Hospital critical care medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

△PCO2/Ca-vO2

ScvO2

Arm Description

△PCO2/Ca-vO2 directed group

ScvO2 directed group

Outcomes

Primary Outcome Measures

mortality

Secondary Outcome Measures

Full Information

First Posted
June 12, 2013
Last Updated
June 13, 2013
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01877798
Brief Title
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy
Official Title
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Severe Sepsis and Septic Shock Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
△PCO2/Ca-vO2
Arm Type
Experimental
Arm Description
△PCO2/Ca-vO2 directed group
Arm Title
ScvO2
Arm Type
Experimental
Arm Description
ScvO2 directed group
Intervention Type
Procedure
Intervention Name(s)
volume resuscitation, vasoactive drug
Primary Outcome Measure Information:
Title
mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Peking Union Medical College Hospital critical care medicine
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Long
Phone
86-010-69152302
Email
ly_icu@aliyun.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30278407
Citation
Su L, Tang B, Liu Y, Zhou G, Guo Q, He W, Wang C, Zhuang H, Jiang L, Qin L, Deng Q, Shuai W, Zhang L, Wang X, Su J, Ma S, Liu D, Long Y. P(v-a)CO2/C(a-v)O2-directed resuscitation does not improve prognosis compared with SvO2 in severe sepsis and septic shock: A prospective multicenter randomized controlled clinical study. J Crit Care. 2018 Dec;48:314-320. doi: 10.1016/j.jcrc.2018.09.009. Epub 2018 Sep 11.
Results Reference
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Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy

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