ShockNCT05220696
Central Venous Oxygen Saturation and Carbone Dioxide (CO2)-Derived Indices in the Critically:
An observational study of Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 20 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- All consecutive critically ill patients who had an arterial catheter and a venous catheter in the superior and inferior vena cava were included.
Who cannot join
- An age under 18
- Pregnancy
- Legally protected adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Venous Oxygen Saturation and Carbone Dioxide (CO2)-Derived Indices in the Critically: Correlation of Measurements According to the Site of Harvest (Femoral Versus Jugular Vein)
The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference [D(a-v) O2]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock.
The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons… In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory.
During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.
- Conditions
- Shock
- Keywords
- Adult > 18 YO, Venous catheter in femoral and jugular sites, Arterial catheter, central venous to arterial carbon dioxide difference, central venous to arterial carbon dioxide difference to arterial to venous oxygen difference, central venous oxygen saturation
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with shock | Critically ill patients with shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of the measurement of indices derived from carbon dioxide (CO2)
To assess the correlation of the measurement of indices derived from carbon dioxide (CO2) according to the femoral or jugular harvest site in the critically ill patient. Measurements included venous pCO2 and pO2, and central venous saturation ; arterial pO2 and pCO2.
From these measurements, carbon dioxides and oxygen variables were calculated as follows :
PCO2gap= Pv-aCO2= PvCO2 -PaCO2, where PaCO2 and PvCO2 represent their arterial and venous partial pressures respectively D(a-v)O2= CaO2- CvO2= [(hg x SaO2 x 1.34) + (Pa02 x O.OO3)]- [(hg x SvO2 x 1.34) + (Pv02 x O.OO3)], where CaO2 and CvO2 are the arterial and venous 02 content, PaO2 and PvO2 represent their arterial and venous partial pressures respectively.
Venous measurements are realized in both venous jugular and femoral sites.
Measured: day 1
Secondary outcomes (1)
To assess the correlation of the measurement of venous O2 saturation
To assess the correlation of the measurement of venous O2 saturation according to the femoral or jugular harvest site. To find a simple equation allowing to calculate the gasometric parameters superior vena cava PCO2 gap and ratio PCO2gap / D (a-v) O2 from measurements made at the femoral level
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Jul 2020
- Primary completion1 Oct 2020
- Study completion20 Oct 2020
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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kada KLOUCHE, MD PhD, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220696
- Sponsor's protocol ID
- RECHMPL22_0003
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Oxygen Saturation and Carbone Dioxide (CO2)-Derived Indices in the Critically: Correlation of Measurements According to the Site of Harvest (Femoral Versus Jugular Vein)
- ClinicalTrials.gov ID
- NCT05220696
- Acronym / sponsor ID
- RECHMPL22_0003
- Conditions
- Shock
- Keywords
- Adult > 18 YO, Venous catheter in femoral and jugular sites, Arterial catheter, central venous to arterial carbon dioxide difference, central venous to arterial carbon dioxide difference to arterial to venous oxygen difference, central venous oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 2 Feb 2022 (actual)
- 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.
The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference [D(a-v) O2]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock.
The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons… In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory.
During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with shock | – | –Critically ill patients with shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- All consecutive critically ill patients who had an arterial catheter and a venous catheter in the superior and inferior vena cava were included.
Key exclusion criteria (3 listed)
- An age under 18
- Pregnancy
- Legally protected adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation of the measurement of indices derived from carbon dioxide (CO2)
Time frame: day 1
To assess the correlation of the measurement of indices derived from carbon dioxide (CO2) according to the femoral or jugular harvest site in the critically ill patient. Measurements included venous pCO2 and pO2, and central venous saturation ; arterial pO2 and pCO2. From these measurements, carbon dioxides and oxygen variables were calculated as follows : PCO2gap= Pv-aCO2= PvCO2 -PaCO2, where PaCO2 and PvCO2 represent their arterial and venous partial pressures respectively D(a-v)O2= CaO2- CvO2= [(hg x SaO2 x 1.34) + (Pa02 x O.OO3)]- [(hg x SvO2 x 1.34) + (Pv02 x O.OO3)], where CaO2 and CvO2 are the arterial and venous 02 content, PaO2 and PvO2 represent their arterial and venous partial pressures respectively. Venous measurements are realized in both venous jugular and femoral sites.
1 secondary outcome
To assess the correlation of the measurement of venous O2 saturation
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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.
Kada KLOUCHE, MD PhD study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by University Hospital, Montpellier at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 2 Feb 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation of the measurement of indices derived from carbon dioxide (CO2) (time frame: day 1). 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 2 Feb 2022.