SepsisNCT07920237
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
An observational study of Sepsis and Circulatory Instability, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This is a single-center prospective clinical study in the intensive care unit (ICU). Thirty adult patients with sepsis requiring hemodynamic monitoring and fluid resuscitation will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Circulatory Instability, Hemodynamic Monitoring
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- 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: Adult critically ill patients with sepsis admitted to the intensive care unit, who require hemodynamic monitoring with PiCCO and APCO for fluid resuscitation and volume assessment.
Who may be able to join
- Age ≥18 years, admitted to the intensive care unit;
- Diagnosed with sepsis according to Sepsis-3 criteria: suspected or confirmed infection with an acute increase in SOFA score ≥2 points from baseline;
- Requiring hemodynamic monitoring for volume assessment and fluid resuscitation due to sepsis;
- Successfully inserted with central venous catheter and radial arterial catheter, meeting the technical requirements for PiCCO and APCO measurements;
- Informed consent signed by the patient or legal surrogate.
Who cannot join
- Severe arrhythmia (e.g., atrial fibrillation, ventricular tachycardia) precluding pulse contour analysis;
- Abnormal arterial access site (e.g., severe radial artery disease, arterial malformation) compromising the quality of invasive blood pressure measurement;
- Contraindications to ultrasound examination (e.g., severe thoracic deformity, massive pleural effusion, large intrathoracic space-occupying lesion) that prevents acquisition of clear ultrasound images;
- Contraindications for PiCCO monitoring (e.g., hemorrhagic disorders, aortic aneurysm, large-vessel vasculitis, pulmonary embolism, during extracorporeal circulation);
- Expected ICU stay ≤ 48 hours;
- Any other conditions judged unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy and Decision-Making Value of Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring for Hemodynamic Management in Critically Ill Patients Compared With PiCCO
This is a single-center prospective clinical study in the intensive care unit (ICU). Thirty adult patients with sepsis requiring hemodynamic monitoring and fluid resuscitation will be enrolled. All participants will undergo two hemodynamic monitoring modalities simultaneously: pulse indicator continuous cardiac output (PiCCO) (reference standard) and arterial pulse contour cardiac output (APCO, ultrasound-calibrated pulse-contour cardiac output). The study aims to evaluate the consistency of clinical decision-making for fluid resuscitation guided by APCO compared with PiCCO, and to verify the accuracy of cardiac output (CO) measured by APCO. No investigational drugs will be administered. A standardized fluid challenge will be performed based on clinical indications. Hemodynamic parameters, laboratory results, and adverse events will be collected throughout the ICU stay.
Read the detailed description
Accurate hemodynamic assessment and fluid management are critical for septic patients in ICU. PiCCO using transpulmonary thermodilution is widely regarded as reference standard for cardiac output measurement, but it has limitations including high cost and potential catheter-related complications. APCO combines transthoracic echocardiography calibration with radial-artery pulse contour analysis, which may provide continuous cardiac output monitoring with lower complication risks.
In this prospective self-controlled study, 30 eligible adult sepsis patients fulfilling Sepsis-3 criteria will be recruited at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Each subject will undergo concurrent PiCCO and APCO measurements. Study visits include baseline screening (V1), dynamic monitoring when fluid infusion indication appears (V2), post-resuscitation assessment (V3), and follow-up until PiCCO catheter removal (V4). 500-mL crystalloid fluid challenge over 15 minutes will be conducted for patients with positive fluid responsiveness assessed by passive leg-raising test. Cardiac output (CO), stroke volume index (SVI) and other hemodynamic variables will be recorded synchronously after each fluid challenge. The primary endpoint is consistency of fluid-resuscitation clinical decisions between APCO and PiCCO, assessed by overall agreement rate and Kappa statistics. Secondary endpoints include bias, percentage error, Bland-Altman limits of agreement and correlation of CO values between two techniques. Safety outcomes include incidence of adverse events and device-related complications. Statistical analyses will be performed using SPSS and R software.
- Conditions
- Sepsis, Circulatory Instability, Hemodynamic Monitoring
- Keywords
- Fluid responsiveness, Cardiac output, Picco, APCO, Pulse-contour analysis, Fluid resuscitation, Critically ill, Intensive Care Unit
- Medical subject headings
- Sepsis, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in fluid resuscitation decision-making between PiCCO and APCO
This outcome assesses the overall agreement rate and Kappa value for consistency of clinical fluid resuscitation decision-making guided by PiCCO and APCO measurements.
Measured: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Secondary outcomes (4)
Percentage error of cardiac output (CO) between PiCCO and APCO
This outcome assesses the percentage error of paired cardiac output measurements obtained by PiCCO transpulmonary thermodilution and APCO monitoring.
Measured: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Consistency of cardiac output trend changes after hemodynamic intervention
This outcome assesses the consistency of cardiac output trend changes detected by PiCCO transpulmonary thermodilution and APCO monitoring after hemodynamic intervention.
Measured: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Agreement of cardiac output evaluated by Bland-Altman analysis
Bland-Altman analysis is used to evaluate the agreement of cardiac output measured by PiCCO and APCO.
Measured: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Pearson correlation of CO between PiCCO and APCO
This outcome assesses the Pearson correlation coefficient of paired cardiac output measurements obtained by PiCCO transpulmonary thermodilution and APCO monitoring.
Measured: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Yu, MD, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920237
- Sponsor's protocol ID
- ICU2026016
- Other IDs
- UHCT-IEC-SOP-016-03-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to patient privacy protection and local institutional data regulations. De-identified aggregate study results may be available upon reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Decision-Making Value of Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring for Hemodynamic Management in Critically Ill Patients Compared With PiCCO
- ClinicalTrials.gov ID
- NCT07920237
- Acronym / sponsor ID
- ICU2026016
- Conditions
- Sepsis, Circulatory Instability, Hemodynamic Monitoring
- Keywords
- Fluid responsiveness, Cardiac output, Picco, APCO, Pulse-contour analysis, Fluid resuscitation, Critically ill, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Nov 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.
This is a single-center prospective clinical study in the intensive care unit (ICU). Thirty adult patients with sepsis requiring hemodynamic monitoring and fluid resuscitation will be enrolled. All participants will undergo two hemodynamic monitoring modalities simultaneously: pulse indicator continuous cardiac output (PiCCO) (reference standard) and arterial pulse contour cardiac output (APCO, ultrasound-calibrated pulse-contour cardiac output). The study aims to evaluate the consistency of clinical decision-making for fluid resuscitation guided by APCO compared with PiCCO, and to verify the accuracy of cardiac output (CO) measured by APCO. No investigational drugs will be administered. A standardized fluid challenge will be performed based on clinical indications. Hemodynamic parameters, laboratory results, and adverse events will be collected throughout the ICU stay.
Detailed description
Accurate hemodynamic assessment and fluid management are critical for septic patients in ICU. PiCCO using transpulmonary thermodilution is widely regarded as reference standard for cardiac output measurement, but it has limitations including high cost and potential catheter-related complications. APCO combines transthoracic echocardiography calibration with radial-artery pulse contour analysis, which may provide continuous cardiac output monitoring with lower complication risks.
In this prospective self-controlled study, 30 eligible adult sepsis patients fulfilling Sepsis-3 criteria will be recruited at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Each subject will undergo concurrent PiCCO and APCO measurements. Study visits include baseline screening (V1), dynamic monitoring when fluid infusion indication appears (V2), post-resuscitation assessment (V3), and follow-up until PiCCO catheter removal (V4). 500-mL crystalloid fluid challenge over 15 minutes will be conducted for patients with positive fluid responsiveness assessed by passive leg-raising test. Cardiac output (CO), stroke volume index (SVI) and other hemodynamic variables will be recorded synchronously after each fluid challenge. The primary endpoint is consistency of fluid-resuscitation clinical decisions between APCO and PiCCO, assessed by overall agreement rate and Kappa statistics. Secondary endpoints include bias, percentage error, Bland-Altman limits of agreement and correlation of CO values between two techniques. Safety outcomes include incidence of adverse events and device-related complications. Statistical analyses will be performed using SPSS and R software.
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
- Adult critically ill patients with sepsis admitted to the intensive care unit, who require hemodynamic monitoring with PiCCO and APCO for fluid resuscitation and volume assessment.
Key inclusion criteria (5 listed)
- Age ≥18 years, admitted to the intensive care unit;
- Diagnosed with sepsis according to Sepsis-3 criteria: suspected or confirmed infection with an acute increase in SOFA score ≥2 points from baseline;
- Requiring hemodynamic monitoring for volume assessment and fluid resuscitation due to sepsis;
- Successfully inserted with central venous catheter and radial arterial catheter, meeting the technical requirements for PiCCO and APCO measurements;
- Informed consent signed by the patient or legal surrogate.
Key exclusion criteria (6 listed)
- Severe arrhythmia (e.g., atrial fibrillation, ventricular tachycardia) precluding pulse contour analysis;
- Abnormal arterial access site (e.g., severe radial artery disease, arterial malformation) compromising the quality of invasive blood pressure measurement;
- Contraindications to ultrasound examination (e.g., severe thoracic deformity, massive pleural effusion, large intrathoracic space-occupying lesion) that prevents acquisition of clear ultrasound images;
- Contraindications for PiCCO monitoring (e.g., hemorrhagic disorders, aortic aneurysm, large-vessel vasculitis, pulmonary embolism, during extracorporeal circulation);
- Expected ICU stay ≤ 48 hours;
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
Agreement in fluid resuscitation decision-making between PiCCO and APCO
Time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
This outcome assesses the overall agreement rate and Kappa value for consistency of clinical fluid resuscitation decision-making guided by PiCCO and APCO measurements.
4 secondary outcomes
Percentage error of cardiac output (CO) between PiCCO and APCO
Time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Consistency of cardiac output trend changes after hemodynamic intervention
Time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Agreement of cardiac output evaluated by Bland-Altman analysis
Time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
Pearson correlation of CO between PiCCO and APCO
Time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.
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 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to patient privacy protection and local institutional data regulations. De-identified aggregate study results may be available upon reasonable request to the principal investigator.
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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.
Yuan Yu, MD, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Circulatory Instability, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 5 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
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 Dan Li, MD, PhD (+86-15623420855, lidanld@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in fluid resuscitation decision-making between PiCCO and APCO (time frame: Baseline (enrollment); dynamic monitoring (fluid responsiveness assessment); fluid resuscitation phase (end of early resuscitation); and ≥3 times daily in follow-up until PiCCO catheter removal (expected average 7 days), whichever come first.). 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 5 Nov 2026.