An observational study in Sepsis, Circulatory Instability and Hemodynamic Monitoring, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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
This outcome assesses the consistency of cardiac output trend changes detected by PiCCO transpulmonary thermodilution and APCO monitoring 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
Bland-Altman analysis is used to evaluate the agreement of cardiac output measured by 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.
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.
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.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 7 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →