Circulatory FailureFRANCKNCT02505646
Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept
An observational study of Circulatory Failure, run by Hopital Louis Pradel at 2 sites in France.
Trial summary
Purpose: Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Observational study. No special intervention will be made
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2015to Dec 2016
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient hospitalized in the intensive care unit of the hospital " feme mère enfant " or the cardiologic hospital of BRON who suffer from circulatory failure and for whom the attending physiscian has decided to administer a 10 ml/kg cristalloïd infusion.
Who may be able to join
- Age < 8 years old
- Patient with a circulatory failure defined as follow :
- Treatment including vasopressor or inotrope
- OR macrocirculatory failure
- Heart rate > 2 Standard Deviation (SD)
- Systolic arterial pressure < 2 SD
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- Mean arterial pressure < 2 SD
- Diastolic arterial pressure < 2 SD
- WITH signs of microcirculatory failure
- Capillary refill time > 2 secondes
- Blotch
- Organ dysfunction due to the circulatory failure (Oliguria < 0,5 ml/kg/h, acute lung injury, encephalopathy)
Who cannot join
- Opposition from the parents or the one who holds the parental authority
- Cardiogenic acute pulmonary edema,
- Extreme hemodynamic instability,
- Intra-abdominal hypertension,
- Recent abdominal surgery that does not permit an abdominal compression without causing pain.
- Patient with mechanical circulatory support, such as Extra Corporal Life Support or Berlin-Heart
Show all 12Show fewer
- Patient with congenital cardiopathy with a palliative correction or an incomplete correction
- Open thorax
- Prone position
- Investigators not available
- No security number registration.
- Moribund patient
Trial locations and contacts
2 sites in 1 country.
France2 sites
Intensive care and anesthesiology department, Hôpital Louis Pradel.
Lyon
Pediatric Intensive care, Hôpital Femme Mère Enfant
Lyon
About this study
Purpose:
Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated.
Read more
The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure.
Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg.
Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.
- Conditions
- Circulatory Failure
- Being tested
- Observational study. No special intervention will be made
- Keywords
- circulatory failure, fluid responsiveness, abdominal compression
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study. No special intervention will be madeOther
Data will be recorded in a context of fluid load in a context of circulatory failure. Stroke volume will be monitored, before, after an abdominal compression and after a fluid load.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness
Stroke volume will be measured before and after a calibrated abdominal compression and after a fluid load. Patient will then be sorted in two groups. Responders defined as patient that show an increase in stroke volume after a 10ml/kg fluid load and Fluid non responders, defined as patient that show an increase of less than 15 % in stroke volume. The ROC curve will investigate the ability of stroke volume variation after abdominal compression to predict fluid responsiveness.
Measured: 30 minutes
Secondary outcomes (3)
Ability of the pulse pressure variation after abdominal compression to predict fluid responsiveness
Measured: 30 minutes
Ability of the heart rate variation after abdominal compression to predict fluid responsiveness
Measured: 30 minutes
Correlation between stroke volume variation, heart rate variation, pulse pressure variation between the abdominal compression and the fluid load
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulatory FailureStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Louis Pradel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Jacquet-Lagrèze, Hopital Louis Pradel
- Investigators
- Jean-Luc Fellahi, MD, PhD, Study director, Hôpital Louis Pradel, Hospice Civil de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505646
- Sponsor's protocol ID
- EudraCT/ANSM 2015-A00388-41
- Acronym
- FRANCK
- Status last verified
- Dec 2016
- First submitted
- 16 Jul 2015
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacquet-Lagreze M, Tiberghien N, Evain JN, Hanna N, Courtil-Teyssedre S, Lilot M, Baudin F, Chardonnal L, Bompard D, Koffel C, Portefaix A, Javouhey E, Fellahi JL. Diagnostic accuracy of a calibrated abdominal compression to predict fluid responsiveness in children. Br J Anaesth. 2018 Dec;121(6):1323-1331. doi: 10.1016/j.bja.2018.06.030. Epub 2018 Sep 6.
PubMed 30442260
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept
- ClinicalTrials.gov ID
- NCT02505646
- Acronym / sponsor ID
- FRANCK / EudraCT/ANSM 2015-A00388-41
- Conditions
- Circulatory Failure
- Keywords
- circulatory failure, fluid responsiveness, abdominal compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hopital Louis PradelUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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.
Purpose:
Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated.
The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure.
Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg.
Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient hospitalized in the intensive care unit of the hospital " feme mère enfant " or the cardiologic hospital of BRON who suffer from circulatory failure and for whom the attending physiscian has decided to administer a 10 ml/kg cristalloïd infusion.
Key inclusion criteria (12 listed)
- Age < 8 years old
- Patient with a circulatory failure defined as follow :
- Treatment including vasopressor or inotrope
- OR macrocirculatory failure
- Heart rate > 2 Standard Deviation (SD)
Key exclusion criteria (12 listed)
- Opposition from the parents or the one who holds the parental authority
- Cardiogenic acute pulmonary edema,
- Extreme hemodynamic instability,
- Intra-abdominal hypertension,
- Recent abdominal surgery that does not permit an abdominal compression without causing pain.
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 |
|---|---|---|
| Observational study. No special intervention will be madeData will be recorded in a context of fluid load in a context of circulatory failure. Stroke volume will be monitored, before, after an abdominal compression and after a fluid load. | Other | – |
Primary outcome
Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness
Time frame: 30 minutes
Stroke volume will be measured before and after a calibrated abdominal compression and after a fluid load. Patient will then be sorted in two groups. Responders defined as patient that show an increase in stroke volume after a 10ml/kg fluid load and Fluid non responders, defined as patient that show an increase of less than 15 % in stroke volume. The ROC curve will investigate the ability of stroke volume variation after abdominal compression to predict fluid responsiveness.
3 secondary outcomes
Ability of the pulse pressure variation after abdominal compression to predict fluid responsiveness
Time frame: 30 minutes
Ability of the heart rate variation after abdominal compression to predict fluid responsiveness
Time frame: 30 minutes
Correlation between stroke volume variation, heart rate variation, pulse pressure variation between the abdominal compression and the fluid load
Time frame: 30 minutes
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 28 Dec 2016.
- Derived from this study: PubMed 30442260Jacquet-Lagreze M, Tiberghien N, Evain JN, Hanna N, Courtil-Teyssedre S, Lilot M, Baudin F, Chardonnal L, Bompard D, Koffel C, Portefaix A, Javouhey E, Fellahi JL. Diagnostic accuracy of a calibrated abdominal compression to predict fluid responsiveness in children. Br J Anaesth. 2018 Dec;121(6):1323-1331. doi: 10.1016/j.bja.2018.06.030. Epub 2018 Sep 6.
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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.
Jean-Luc Fellahi, MD, PhD study director
Hôpital Louis Pradel, Hospice Civil de Lyon
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 Circulatory Failure, run by Hopital Louis Pradel 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 12 inclusion and 12 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 28 Dec 2016. 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?
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?
Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505646, which also lists 1 linked publication.
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 28 Dec 2016.