NCT01877798

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

June 12, 2013

Last Update Submit

June 13, 2013

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • mortality

    30 days

Study Arms (2)

△PCO2/Ca-vO2

EXPERIMENTAL

△PCO2/Ca-vO2 directed group

Procedure: volume resuscitation, vasoactive drug

ScvO2

EXPERIMENTAL

ScvO2 directed group

Procedure: volume resuscitation, vasoactive drug

Interventions

volume resuscitation, vasoactive drugPROCEDURE
ScvO2△PCO2/Ca-vO2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe sepsis and septic shock patients

You may not qualify if:

  • \<18 years old
  • pregnant and breast-feed woman
  • AMI
  • cerebral hemorrhage
  • contraindication for central venous catheter or arterial catheter;
  • brainstem death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital critical care medicine

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 30278407DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

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

June 12, 2013

First Posted

June 14, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

CN(1)