Septic ShockMICAPNCT07628023
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring cardiac index by thermodilution. The Swan-Ganz IQ™ model also allows continuous estimation of cardiac index through analysis of the right ventricular pressure wave, which could be useful for rapidly assessing… 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?
- Swan-Ganz
- How many people
- 43 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2026to 16 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.
Who may be able to join
- Age ≥ 18 years
- Hospitalization in intensive care
- Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of treatment
- Thermodilution performed by the clinician in charge as part of treatment
Who cannot join
- Pregnancy
- Legal protective measures (guardianship, conservatorship, and deprivation of liberty by court/administrative decision)
- Refusal of participation by the patient's relatives or the patient themselves.
- Cardiac output measurements by thermodilution or continuous cardiac output analysis that cannot be used.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nicolas FAGE, MD, PhD contact
France2 sites, 2 recruiting
- Recruiting
Pierre ASFAR
Angers, 49100
Pierre ASFAR, PhD, piasfar@chu-angers.fr
- Recruiting
Xavier MONNET
Paris, 94000
Xavier MONNET, PhD, 0145213539, xavier.monnet@aphp.fr
Nicolas FAGE, MD, PhD, nicolas.fage@aphp.fr
About this study
Official title: Comparison of Cardiac Index Measurement by Analysis of the Right Ventricular Pressure Curve and by Thermodilution During Pulmonary Artery Catheterization Using Swan Ganz IQ™.
The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring cardiac index by thermodilution. The Swan-Ganz IQ™ model also allows continuous estimation of cardiac index through analysis of the right ventricular pressure wave, which could be useful for rapidly assessing changes in cardiac output during volume expansion response tests. However, the concordance between this continuous method and thermodilution remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the cardiac index measured by thermodilution with that estimated by right ventricular pressure waveform analysis based on data collected in clinical practice.
Read the detailed description
The pulmonary artery catheter (or Swan-Ganz catheter) is a standard tool for measuring and monitoring cardiac index in intensive care. It measures cardiac index using thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also offers continuous measurement of cardiac index by analyzing the right ventricular pressure waveform. The ability to measure cardiac output continuously would allow pulmonary artery catheterization to be used to assess cardiac output during short procedures, such as tests to predict the response to volume expansion (passive leg raising, expiratory pause), and to evaluate its effect on cardiac index. However, the concordance between cardiac output measured by thermodilution (reference method) and that estimated by the continuous method based on analysis of the right ventricular pressure waveform remains poorly evaluated by independent data in real clinical conditions. Furthermore, this agreement may vary depending on the clinical situation, particularly in the presence of right ventricular dysfunction, tricuspid regurgitation, or left heart failure. In this context, this study aims to compare the cardiac index measured by thermodilution with the cardiac index estimated by analyzing the right ventricular pressure waveform, based on data collected in the clinical setting.
- Conditions
- Septic Shock
- Being tested
- Swan-Ganz
- Keywords
- Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-GanzDiagnostic test
The pulmonary artery catheter (or Swan-Ganz catheter) is a gold-standard tool for measuring and monitoring cardiac index in the intensive care unit. It enables measurement of cardiac index via thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also provides continuous measurement of cardiac index through analysis of the right ventricular pressure wave.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the concordance between cardiac index values provided according to right ventricular pressure waveform and those measured by thermodilution in patients with septic shock who are monitored by a pulmonary.
Measured: 1 day
Secondary outcomes (6)
Evaluate the concordance between the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter and the cardiac index measured by thermodilution in patients receiving vasopressor therapy, compared to patients not receiving vasopressor therapy.
Measured: 1 day
Assess whether the agreement between cardiac index measured by thermodilution and that estimated by Swan-Ganz IQ™ varies across different hemodynamic profiles.
Investigate whether the agreement between the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter and the cardiac index measured by thermodilution differs according to prespecified hemodynamic phenotypes, particularly in the presence of right ventricular dysfunction, left heart failure, and tricuspid regurgitation grade ≥ 3.
Measured: 1 day
Assess the concordance between variations in cardiac index measured by thermodilution and those in continuous cardiac index estimated by right ventricular pressure wave analysis, before and after volume expansion performed as part of treatment.
Measured: 1 day
Assess the consistency of changes in cardiac output before and after volume expansion, depending on the use of vasopressors.
Assess the concordance between changes in cardiac index measured by thermodilution and those estimated by right ventricular pressure wave analysis before and after volume expansion, depending on the presence or absence of vasopressor treatment at the time of measurement.
Measured: 1 day
Assess the agreement between changes in cardiac output measured by thermodilution and those estimated continuously by analysis of the right ventricular pressure wave, before and after a change in the dose of norepinephrine.
Evaluate the concordance between variations in cardiac index measured by thermodilution and those of continuous cardiac index estimated by right ventricular pressure wave analysis, before and after a change in norepinephrine dose administered as part of treatment.
Measured: 1 day
Determine the least significant change (LSC) in the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter, based on the observed measurement variability.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Oct 2026
- Primary completion16 Oct 2028 (estimated)
- Study completion16 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MONNET, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628023
- Sponsor's protocol ID
- APHP260231
- Acronym
- MICAP
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Index Measurement by Analysis of the Right Ventricular Pressure Curve and by Thermodilution During Pulmonary Artery Catheterization Using Swan Ganz IQ™.
- ClinicalTrials.gov ID
- NCT07628023
- Acronym / sponsor ID
- MICAP / APHP260231
- Conditions
- Septic Shock
- Keywords
- Swan-Ganz IQ™, Swan-Ganz, thermodilution, cardiac index.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 16 Oct 2028 (estimated)
- First posted
- 4 Jun 2026 (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 pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring cardiac index by thermodilution. The Swan-Ganz IQ™ model also allows continuous estimation of cardiac index through analysis of the right ventricular pressure wave, which could be useful for rapidly assessing changes in cardiac output during volume expansion response tests. However, the concordance between this continuous method and thermodilution remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the cardiac index measured by thermodilution with that estimated by right ventricular pressure waveform analysis based on data collected in clinical practice.
Detailed description
The pulmonary artery catheter (or Swan-Ganz catheter) is a standard tool for measuring and monitoring cardiac index in intensive care. It measures cardiac index using thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also offers continuous measurement of cardiac index by analyzing the right ventricular pressure waveform. The ability to measure cardiac output continuously would allow pulmonary artery catheterization to be used to assess cardiac output during short procedures, such as tests to predict the response to volume expansion (passive leg raising, expiratory pause), and to evaluate its effect on cardiac index. However, the concordance between cardiac output measured by thermodilution (reference method) and that estimated by the continuous method based on analysis of the right ventricular pressure waveform remains poorly evaluated by independent data in real clinical conditions. Furthermore, this agreement may vary depending on the clinical situation, particularly in the presence of right ventricular dysfunction, tricuspid regurgitation, or left heart failure. In this context, this study aims to compare the cardiac index measured by thermodilution with the cardiac index estimated by analyzing the right ventricular pressure waveform, based on data collected in the clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Hospitalization in intensive care
- Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of treatment
- Thermodilution performed by the clinician in charge as part of treatment
Key exclusion criteria (4 listed)
- Pregnancy
- Legal protective measures (guardianship, conservatorship, and deprivation of liberty by court/administrative decision)
- Refusal of participation by the patient's relatives or the patient themselves.
- Cardiac output measurements by thermodilution or continuous cardiac output analysis that cannot be used.
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 |
|---|---|---|
| Swan-GanzThe pulmonary artery catheter (or Swan-Ganz catheter) is a gold-standard tool for measuring and monitoring cardiac index in the intensive care unit. It enables measurement of cardiac index via thermodilution, which is considered the gold standard method. The Swan-Ganz IQ™ model also provides continuous measurement of cardiac index through analysis of the right ventricular pressure wave. | Diagnostic test | – |
Primary outcome
Evaluate the concordance between cardiac index values provided according to right ventricular pressure waveform and those measured by thermodilution in patients with septic shock who are monitored by a pulmonary.
Time frame: 1 day
6 secondary outcomes
Evaluate the concordance between the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter and the cardiac index measured by thermodilution in patients receiving vasopressor therapy, compared to patients not receiving vasopressor therapy.
Time frame: 1 day
Assess whether the agreement between cardiac index measured by thermodilution and that estimated by Swan-Ganz IQ™ varies across different hemodynamic profiles.
Time frame: 1 day
Assess the concordance between variations in cardiac index measured by thermodilution and those in continuous cardiac index estimated by right ventricular pressure wave analysis, before and after volume expansion performed as part of treatment.
Time frame: 1 day
Assess the consistency of changes in cardiac output before and after volume expansion, depending on the use of vasopressors.
Time frame: 1 day
Assess the agreement between changes in cardiac output measured by thermodilution and those estimated continuously by analysis of the right ventricular pressure wave, before and after a change in the dose of norepinephrine.
Time frame: 1 day
Determine the least significant change (LSC) in the continuous cardiac index estimated by the Swan-Ganz IQ™ catheter, based on the observed measurement variability.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Sepsis
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.
Nicolas FAGE, MD, PhD contact
Xavier MONNET, PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier MONNET, PhD (0145213539, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the concordance between cardiac index values provided according to right ventricular pressure waveform and those measured by thermodilution in patients with septic shock who are monitored by a pulmonary. (time frame: 1 day). 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 27 Oct 2026.