Septic ShockNCT01877798
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy
A study testing volume resuscitation, vasoactive drug in people with Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- volume resuscitation, vasoactive drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe sepsis and septic shock patients
Who cannot join
- <18 years old
- pregnant and breast-feed woman
- AMI
- cerebral hemorrhage
- contraindication for central venous catheter or arterial catheter;
- brainstem death
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital critical care medicine
Beijing
Yun Long, 86-010-69152302, ly_icu@aliyun.com
About this study
Official title: 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.
- Conditions
- Septic Shock
- Being tested
- volume resuscitation, vasoactive drug
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume resuscitation, vasoactive drugProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| △PCO2/Ca-vO2 | Experimental | △PCO2/Ca-vO2 directed group Receives: Procedure: volume resuscitation, vasoactive drug |
| ScvO2 | Experimental | ScvO2 directed group Receives: Procedure: volume resuscitation, vasoactive drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877798
- Sponsor's protocol ID
- PCSS
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30278407
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Severe Sepsis and Septic Shock Therapy
- ClinicalTrials.gov ID
- NCT01877798
- Acronym / sponsor ID
- PCSS
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| △PCO2/Ca-vO2 | Experimental | Procedure: volume resuscitation, vasoactive drug△PCO2/Ca-vO2 directed group |
| ScvO2 | Experimental | Procedure: volume resuscitation, vasoactive drugScvO2 directed group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe sepsis and septic shock patients
Key exclusion criteria (6 listed)
- <18 years old
- pregnant and breast-feed woman
- AMI
- cerebral hemorrhage
- contraindication for central venous catheter or arterial catheter;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volume resuscitation, vasoactive drug | Procedure or surgery | ScvO2, △PCO2/Ca-vO2 |
Primary outcome
mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Derived from this study: PubMed 30278407Su 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peking Union Medical College Hospital critical care medicine
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing volume resuscitation, vasoactive drug in people with Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.