ShockgapCO2NCT02867943
GapCO2 and Respiratory Rate in Patients Under Volume Mechanical Ventilation
An observational study of Shock, run by 105 Hospital of Chinese People's Liberation Army.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shock
- What is being tested?
- Effects of respiratory rate on gapCO2
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2016
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria were pregnancy, COPD，age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate>140 beats/min).
About this study
Official title: Effects of Respiratory Rate on Venous-to-arterial CO2 Tension Difference in Septic Shock Patients Under Volume Mechanical Ventilation
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.
Read the detailed description
An increased ∆PCO2 (> 6 mmHg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (ScvO2) > 70% associated with elevated blood lactate levels.
Under steady states of both VO2 and VCO2, P (v-a) CO2 was observed to increase in parallel with the reduction in cardiac output. However, spontaneous breathing and hyperventilation may reduce PaCO2 and prevent the CO2 stagnation-induced rise in PvCO2.
To date,these studies of ∆PCO2 and respiratory rate in septic shock patients Under Volume Mechanical Ventilation are rarely.
- Conditions
- Shock
- Being tested
- Effects of respiratory rate on gapCO2
- Keywords
- sepsis, shock,Lactate,volume controlled ventilation
- Medical subject headings
- Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of respiratory rate on gapCO2Other
respiratory rate was started at 10 breaths/min and added by 2 breaths/min every 60 min up to 16 breaths/min
| Study group | Role | What they receive |
|---|---|---|
| respiratory rate is 10 breaths/min | GapCO2=Pv-aCO2 = PvCO2 - PaCO2;
Effects of venous-to-arterial CO2 tension difference after increased respiratory rate. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Effects of respiratory rate on gapCO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 105 Hospital of Chinese People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867943
- Sponsor's protocol ID
- PLA-105-ICU
- Acronym
- gapCO2
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Rate on Venous-to-arterial CO2 Tension Difference in Septic Shock Patients Under Volume Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02867943
- Acronym / sponsor ID
- gapCO2 / PLA-105-ICU
- Conditions
- Shock
- Keywords
- sepsis, shock,Lactate,volume controlled ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- 105 Hospital of Chinese People's Liberation ArmyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Aug 2016 (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.
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.
Detailed description
An increased ∆PCO2 (> 6 mmHg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (ScvO2) > 70% associated with elevated blood lactate levels.
Under steady states of both VO2 and VCO2, P (v-a) CO2 was observed to increase in parallel with the reduction in cardiac output. However, spontaneous breathing and hyperventilation may reduce PaCO2 and prevent the CO2 stagnation-induced rise in PvCO2.
To date,these studies of ∆PCO2 and respiratory rate in septic shock patients Under Volume Mechanical Ventilation are rarely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| respiratory rate is 10 breaths/min | – | Other: Effects of respiratory rate on gapCO2GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate. |
| respiratory rate is 12 breaths/min | – | Other: Effects of respiratory rate on gapCO2GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate. |
| respiratory rate is 14 breaths/min | – | Other: Effects of respiratory rate on gapCO2GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate. |
| respiratory rate is 16 breaths/min | – | Other: Effects of respiratory rate on gapCO2GapCO2=Pv-aCO2 = PvCO2 - PaCO2; Effects of venous-to-arterial CO2 tension difference after increased respiratory rate. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria were pregnancy, COPD，age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate>140 beats/min).
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 |
|---|---|---|
| Effects of respiratory rate on gapCO2respiratory rate was started at 10 breaths/min and added by 2 breaths/min every 60 min up to 16 breaths/min | Other | respiratory rate is 10 breaths/min, respiratory rate is 12 breaths/min, respiratory rate is 14 breaths/min, respiratory rate is 16 breaths/min |
Primary outcome
Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by 105 Hospital of Chinese People's Liberation Army.
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 1 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2016.