HypovolemiaMOSTCARE-PEDNCT04186416
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
An observational study of Hypovolemia and Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Hypovolemia, Hemorrhage, Fluid Responsiveness
- What is being tested?
- Mostcare® device and Transthoracic cardiac ultrasound
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2023to 3 Nov 2025
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients between birth and 10 years of age admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.
Who may be able to join
- Children aged 0 to 10 years old, of both sexes.
- Perioperative period of surgery under general anesthesia requiring admission to surgical resuscitation (before and / or after the surgical procedure).
- Patients admitted for severe trauma.
- Patient installation: supine position.
- Intubation and mechanical ventilation: tidal volume: 7 to 8 ml / kg, Positive expiratory pressure : 3-4 cm H2O, inspiration / expiration: 1 / 1.5 to 1/2; respiratory rate: 1 month up to 2 years = 30 / min; children 2-8 years = 20 / min; children> 8 years = 15 / min.
- Patients with arterial catheters.
- Need for a volume expansion : indication given by the doctor in charge of the patient.
- Non-opposition expressed by the holders of parental authority.
Who cannot join
- Cardiac rhythm disorders (in particular atrial fibrillation, junctional tachycardia, ventricular arrhythmias), with the exception of sinus tachycardia, respiratory variations of heart rate and sporadic atrial / ventricular extrasystoles whom will allow inclusion.
- Cardiopathy: severe systolic dysfunction (shortening fraction <28%, ejection fraction <50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct.
- Unstable hemodynamic status related to active bleeding requiring vascular filling > 2 mL / kg / min or requiring vasopressor or inotropic therapy whose dosage had to be changed in the last five minutes.
- Need for mechanical ventilation with a tidal volume> 10 mL / kg or <7 mL / kg.
- Refusal of the patient or the holders of parental authority to exploit the collected data.
- Impossibility to carry out measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system.
The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.
Read the detailed description
Children undergoing major surgery or severe trauma with bleeding require regular hemodynamic evaluation, including cardiac output measurement, to maintain adequate organ perfusion. In fact, administration of fluid to improve cardiac output is the mainstay of hemodynamic resuscitation. However, not all patients respond to fluid therapy, and excessive fluid administration is harmful. Therefore, the vascular filling strategy requires a thorough hemodynamic evaluation.
Many predictive tools for fluid responsiveness have been validated in adults, and are based on heart-lung interaction in ventilated patients. Up to now, respiratory variation in aortic blood flow peak velocity, measured by transthoracic or transoesophageal cardiac echocardiography, is the only variable shown to effectively predict fluid responsiveness in children.
However, the use of these methods does not allow continuous monitoring (trans-thoracic echocardiography) or is not easily achievable in current practice (trans-esophageal echocardiography). In addition, these monitoring tools require learning and inter- and intra-individual variability is not negligible, ranging from 1% to 20%.
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system, that allows a continuous estimation of the stroke volume and thus of the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system.
The goal of this study is to assess the ability of dynamic cardiovascular variables measured using Mostcare® to predict fluid responsiveness in pediatric surgical critical care patients, sedated, intubated and ventilated, in prone position, by comparing the changes in stroke volume (SV), induced by a volume expansion (VE), measured by trans-thoracic echocardiography. For the purpose of the study, responders (Rs) to VE are patients showing an increase in SV measured using transthoracic echocardiography of at least 15% after VE.
- Conditions
- Hypovolemia, Hemorrhage, Fluid Responsiveness
- Being tested
- Mostcare® device, Transthoracic cardiac ultrasound
- Keywords
- Volume expansion in children, Mostcare® device, Fluid responsiveness, Stroke volume, Transthoracic cardiac echocardiography
- Medical subject headings
- Hypovolemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mostcare® deviceOther
The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.
Transthoracic cardiac ultrasoundOther
Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
| Study group | Role | What they receive |
|---|---|---|
| Patients less than 6 months old | Patients less than 6 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. Receives: Other: Mostcare® device; Other: Transthoracic cardiac ultrasound | |
| Patients between 6 and 12 months old | Patients between 6 and 12 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. Receives: Other: Mostcare® device; Other: Transthoracic cardiac ultrasound | |
| Patients between 1 and 6 years old | Patients between 1 and 6 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. Receives: Other: Mostcare® device; Other: Transthoracic cardiac ultrasound | |
| Patients between 6 and 10 years old | Patients between 6 and 10 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. Receives: Other: Mostcare® device; Other: Transthoracic cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation from Mostcare®
Predictability of stroke volume variation (SVV) from Mostcare® for fluid responsiveness.
Patients are defined as responders if stroke volume obtained using echocardiography increased by ≥15% after volume expansion.
Measured: 5 minutes after infusion of bolus fluid
Secondary outcomes (2)
Absolute values and variation of cardiac output (CO) and cardiac index (CI) from Mostcare®
Correlation with CO and CI measured by transthoracic cardiac ultrasound before and after volume expansion.
Measured: 5 minutes after infusion of bolus fluid
Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare®
Correlation with SV and SVi by transthoracic cardiac ultrasound before and after volume expansion.
Measured: 5 minutes after infusion of bolus fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start3 May 2023
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gilles Orliaguet, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisEstelle Vergnaud, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186416
- Sponsor's protocol ID
- APHP191036
- Other IDs
- 2019-A02804-53
- Acronym
- MOSTCARE-PED
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2019
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Pressure Recording Analytical Method in Predicting the Fluid Responsiveness in Pediatric Surgical Critical Care Patients
- ClinicalTrials.gov ID
- NCT04186416
- Acronym / sponsor ID
- MOSTCARE-PED / APHP191036
- Conditions
- Hypovolemia, Hemorrhage, Fluid Responsiveness
- Keywords
- Volume expansion in children, Mostcare® device, Fluid responsiveness, Stroke volume, Transthoracic cardiac echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 4 Dec 2019 (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 Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system.
The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.
Detailed description
Children undergoing major surgery or severe trauma with bleeding require regular hemodynamic evaluation, including cardiac output measurement, to maintain adequate organ perfusion. In fact, administration of fluid to improve cardiac output is the mainstay of hemodynamic resuscitation. However, not all patients respond to fluid therapy, and excessive fluid administration is harmful. Therefore, the vascular filling strategy requires a thorough hemodynamic evaluation.
Many predictive tools for fluid responsiveness have been validated in adults, and are based on heart-lung interaction in ventilated patients. Up to now, respiratory variation in aortic blood flow peak velocity, measured by transthoracic or transoesophageal cardiac echocardiography, is the only variable shown to effectively predict fluid responsiveness in children.
However, the use of these methods does not allow continuous monitoring (trans-thoracic echocardiography) or is not easily achievable in current practice (trans-esophageal echocardiography). In addition, these monitoring tools require learning and inter- and intra-individual variability is not negligible, ranging from 1% to 20%.
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system, that allows a continuous estimation of the stroke volume and thus of the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system.
The goal of this study is to assess the ability of dynamic cardiovascular variables measured using Mostcare® to predict fluid responsiveness in pediatric surgical critical care patients, sedated, intubated and ventilated, in prone position, by comparing the changes in stroke volume (SV), induced by a volume expansion (VE), measured by trans-thoracic echocardiography. For the purpose of the study, responders (Rs) to VE are patients showing an increase in SV measured using transthoracic echocardiography of at least 15% after VE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients less than 6 months old | – | Other: Mostcare® device, Other: Transthoracic cardiac ultrasoundPatients less than 6 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| Patients between 6 and 12 months old | – | Other: Mostcare® device, Other: Transthoracic cardiac ultrasoundPatients between 6 and 12 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| Patients between 1 and 6 years old | – | Other: Mostcare® device, Other: Transthoracic cardiac ultrasoundPatients between 1 and 6 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
| Patients between 6 and 10 years old | – | Other: Mostcare® device, Other: Transthoracic cardiac ultrasoundPatients between 6 and 10 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients between birth and 10 years of age admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.
Key inclusion criteria (8 listed)
- Children aged 0 to 10 years old, of both sexes.
- Perioperative period of surgery under general anesthesia requiring admission to surgical resuscitation (before and / or after the surgical procedure).
- Patients admitted for severe trauma.
- Patient installation: supine position.
- Intubation and mechanical ventilation: tidal volume: 7 to 8 ml / kg, Positive expiratory pressure : 3-4 cm H2O, inspiration / expiration: 1 / 1.5 to 1/2; respiratory rate: 1 month up to 2 years = 30 / min; children 2-8 years = 20 / min; children> 8 years = 15 / min.
Key exclusion criteria (6 listed)
- Cardiac rhythm disorders (in particular atrial fibrillation, junctional tachycardia, ventricular arrhythmias), with the exception of sinus tachycardia, respiratory variations of heart rate and sporadic atrial / ventricular extrasystoles whom will allow inclusion.
- Cardiopathy: severe systolic dysfunction (shortening fraction <28%, ejection fraction <50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct.
- Unstable hemodynamic status related to active bleeding requiring vascular filling > 2 mL / kg / min or requiring vasopressor or inotropic therapy whose dosage had to be changed in the last five minutes.
- Need for mechanical ventilation with a tidal volume> 10 mL / kg or <7 mL / kg.
- Refusal of the patient or the holders of parental authority to exploit the collected data.
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 |
|---|---|---|
| Mostcare® deviceThe Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling. | Other | Patients between 1 and 6 years old, Patients between 6 and 10 years old, Patients between 6 and 12 months old, Patients less than 6 months old |
| Transthoracic cardiac ultrasoundTransthoracic cardiac ultrasound before and 3 minutes after the vascular filling. | Other | Patients between 1 and 6 years old, Patients between 6 and 10 years old, Patients between 6 and 12 months old, Patients less than 6 months old |
Primary outcome
Stroke volume variation from Mostcare®
Time frame: 5 minutes after infusion of bolus fluid
Predictability of stroke volume variation (SVV) from Mostcare® for fluid responsiveness. Patients are defined as responders if stroke volume obtained using echocardiography increased by ≥15% after volume expansion.
2 secondary outcomes
Absolute values and variation of cardiac output (CO) and cardiac index (CI) from Mostcare®
Time frame: 5 minutes after infusion of bolus fluid
Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare®
Time frame: 5 minutes after infusion of bolus fluid
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gilles Orliaguet, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Estelle Vergnaud, MD study director
Assistance Publique - Hôpitaux de Paris
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 Hypovolemia and Hemorrhage, run by Assistance Publique - Hôpitaux de Paris 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 8 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: finished, as of the sponsor's last update on 1 Jul 2026. 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?
Stroke volume variation from Mostcare® (time frame: 5 minutes after infusion of bolus fluid). 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 1 Jul 2026.