NCT02867943

Brief Summary

As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is proportional to CO2 production and inversely related to cardiac output (Fick equation). Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because of buffering of bicarbonate ions by the protons produced in excess secondary to the hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue hypoxia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Status
unknown

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

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 11, 2016

Last Update Submit

August 16, 2016

Conditions

Keywords

sepsis, shock,Lactate,volume controlled ventilation

Outcome Measures

Primary Outcomes (1)

  • Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation

    1 year

Study Arms (4)

respiratory rate is 10 breaths/min

GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

Other: Effects of respiratory rate on gapCO2

respiratory rate is 12 breaths/min

GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

Other: Effects of respiratory rate on gapCO2

respiratory rate is 14 breaths/min

GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

Other: Effects of respiratory rate on gapCO2

respiratory rate is 16 breaths/min

GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

Other: Effects of respiratory rate on gapCO2

Interventions

respiratory rate was started at 10 breaths/min and added by 2 breaths/min every 60 min up to 16 breaths/min

respiratory rate is 10 breaths/minrespiratory rate is 12 breaths/minrespiratory rate is 14 breaths/minrespiratory rate is 16 breaths/min

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects were sequentially admitted to the Department of Critical Care Medicine of 105 Hospital of PLA from March of 2016 till the end of this study.

You may qualify if:

  • Patients were included in the study, if the attending physician find the persistence of signs of hypoperfusion (oliguria, mottled skin, central venous oxygen saturation (ScvO2) \<70 % despite a hemoglobin \> 8 g/dl),despite achieving adequate intravascular volume and adequate mean arterial pressure (MAP) \> 65 mmHg as recommended by the Surviving Sepsis Campaign.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ShockSepsis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share