VCO2 Variation in Intensive Care as a Marker of Fluid ResponsivenessCRACNCT05430880
Cardiac Responsiveness Assessment by CO2
An observational study of VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness and Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness. Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness, Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock
- What is being tested?
- impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Sep 2023
- How long will I take part?
- 1 Day
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study concerns adult subjects in intensive care with a state of circulatory failure (shock), in whom the indication of fluid vascular filling is to be discussed.
Who may be able to join
- Patient hospitalized in intensive care.
- Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
- Patient with hypotension (MAP <65 mmHg OR SAP <90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
- Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior or inferior vena cava territory.
Who cannot join
- Patient under 18 years old
- Patient under guardianship without the possible consent of the guardian
- Pregnant woman
- Pathologies and maneuvers strongly affecting CO2 purification: Diagnosed pulmonary embolism, Prone positioning for less than 60 minutes, Exogenous intake of sodium bicarbonate less than 60 minutes ago (with the exception of an renal replacement therapy in place for more than 60 minutes)
- Recent change in respiratory quotient: Change in enteral or parenteral nutrition solution for less than 3 hours
- Pathology affecting CO2 metabolism: Fever> 39 ° c, Intense chills.
- Patients with unstable ventilation over the hour before inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot, Anesthésie-réanimation
Lyon, 69003
FLORENT SIGWALT, +33 6 88 62 01 69, florent.sigwalt@chu-lyon.fr
PAULINE SAMBIN, + 33 6 74 02 96 74, pauline.sambin@chu-lyon.fr
About this study
Official title: Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit
The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness.
Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful.
Read more
To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity).
The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring.
Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases.
There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism.
The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output.
The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.
- Conditions
- VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness, Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock
- Being tested
- impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)
- Keywords
- cardiac output, VCO2, fluid responsiveness, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)Diagnostic test
Preliminary daily data will record: demographic, ventilatory (tidal volume, FiO2, positive expiratory pressure, compliance, respiratory rate, I/E ratio) and biological parameters (fibrinogen, CRP, leukocytes count, PaO2, PvO2, PaCO2, PvCO2, CO2gap, arterial lactate, ScvO2, platelets count)
- st step CO2 record (between Time-6minutes and T0; T0 corresponding to fluid challenge) VCO2 and EtCO2 (End-tidal CO2) automated measurement by Hamilton module. Average VCO2 obtained before fluid challenge. CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli.
- nd step: Crystalloid (ringer lactate) filling 500mL in 5 minutes
- rd step CO2 record (between T+5min and Time+11minutes): VCO2 and EtCO2: automated measurement by Hamilton module. Average VCO2 obtained after fluid challenge.
CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli
| Study group | Role | What they receive |
|---|---|---|
| "CRAC" patients : ICU patients ventilated and shocked | Patient hospitalized in intensive care.
Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
Patient with hypotension (MAP <65 mmHg OR SAP <90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior vena cava territory.
Inclusion after agreement of the patient or his trusted person after validation of the inclusion criteria and verification of the absence of exclusion criteria. Receives: Diagnostic Test: impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main endpoint is the performance of the variation of the VCO2 (noted ΔVCO2 after obtaining an average before vascular filling VCO2m1 and an average after vascular filling VCO2m2) in ml/min in the detection of fluid-responsiveness.
The investigators will analyze the VCO2 variation performance to detect fluid responsiveness as established by the sensitivity, specificity, positive and negative predictive values as well as by analysis of the ROC curve. The Gold Standard used as a comparator for this test is the change in cardiac index (ΔIC in L/min/m2) measured by transpulmonary thermodilution before / after fluid challenge and considered significant if greater than or equal to 10%.
Measured: at the inclusion during less than fifteen minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VCO2 Variation in Intensive Care as a Marker of Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430880
- Sponsor's protocol ID
- 485
- Acronym
- CRAC
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05430880
- Acronym / sponsor ID
- CRAC / 485
- Conditions
- VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness, Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock
- Keywords
- cardiac output, VCO2, fluid responsiveness, Intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Jun 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 increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness.
Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful.
To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity).
The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring.
Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases.
There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism.
The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output.
The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "CRAC" patients : ICU patients ventilated and shocked | – | Diagnostic Test: impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)Patient hospitalized in intensive care. Patient sedated and mechanically ventilated in Volume Assisted Controlled mode. Patient with hypotension (MAP <65 mmHg OR SAP <90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior vena cava territory. Inclusion after agreement of the patient or his trusted person after validation of the inclusion criteria and verification of the absence of exclusion criteria. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study concerns adult subjects in intensive care with a state of circulatory failure (shock), in whom the indication of fluid vascular filling is to be discussed.
Key inclusion criteria (4 listed)
- Patient hospitalized in intensive care.
- Patient sedated and mechanically ventilated in Volume Assisted Controlled mode.
- Patient with hypotension (MAP <65 mmHg OR SAP <90 mmHg) AND / OR under continuous infusion of Norepinephrine / Dobutamine / Epinephrine
- Patient equipped with a cardiac output measurement system by transpulmonary thermodilution (PICCO®) with a femoral arterial module; as well as a central venous route in the superior or inferior vena cava territory.
Key exclusion criteria (7 listed)
- Patient under 18 years old
- Patient under guardianship without the possible consent of the guardian
- Pregnant woman
- Pathologies and maneuvers strongly affecting CO2 purification: Diagnosed pulmonary embolism, Prone positioning for less than 60 minutes, Exogenous intake of sodium bicarbonate less than 60 minutes ago (with the exception of an renal replacement therapy in place for more than 60 minutes)
- Recent change in respiratory quotient: Change in enteral or parenteral nutrition solution for less than 3 hours
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 |
|---|---|---|
| impact of fluid challenge on the cardiac index and CO2 respiratory parameters analysis (VCO2, EtCO2)Preliminary daily data will record: demographic, ventilatory (tidal volume, FiO2, positive expiratory pressure, compliance, respiratory rate, I/E ratio) and biological parameters (fibrinogen, CRP, leukocytes count, PaO2, PvO2, PaCO2, PvCO2, CO2gap, arterial lactate, ScvO2, platelets count) 1. st step CO2 record (between Time-6minutes and T0; T0 corresponding to fluid challenge) VCO2 and EtCO2 (End-tidal CO2) automated measurement by Hamilton module. Average VCO2 obtained before fluid challenge. CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli. 2. nd step: Crystalloid (ringer lactate) filling 500mL in 5 minutes 3. rd step CO2 record (between T+5min and Time+11minutes): VCO2 and EtCO2: automated measurement by Hamilton module. Average VCO2 obtained after fluid challenge. CI (cardiac index): measurement by calibration of the PiCCO module with 3 cold boli | Diagnostic test | "CRAC" patients : ICU patients ventilated and shocked |
Primary outcome
The main endpoint is the performance of the variation of the VCO2 (noted ΔVCO2 after obtaining an average before vascular filling VCO2m1 and an average after vascular filling VCO2m2) in ml/min in the detection of fluid-responsiveness.
Time frame: at the inclusion during less than fifteen minutes
The investigators will analyze the VCO2 variation performance to detect fluid responsiveness as established by the sensitivity, specificity, positive and negative predictive values as well as by analysis of the ROC curve. The Gold Standard used as a comparator for this test is the change in cardiac index (ΔIC in L/min/m2) measured by transpulmonary thermodilution before / after fluid challenge and considered significant if greater than or equal to 10%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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.
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 VCO2 Variation in Intensive Care as a Marker of Fluid Responsiveness and Cardiac Index Variation Transpulmonary Thermodilution in Patients on Controlled Ventilation With Shock, run by Hospices Civils de Lyon 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 4 inclusion and 7 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 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FLORENT SIGWALT (06 88 62 01 69 ext. +33, florent.sigwalt@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main endpoint is the performance of the variation of the VCO2 (noted ΔVCO2 after obtaining an average before vascular filling VCO2m1 and an average after vascular filling VCO2m2) in ml/min in the detection of fluid-responsiveness. (time frame: at the inclusion during less than fifteen minutes). 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 24 Jun 2022.