HypovolemiaNCT03145935
Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.
An observational study of Hypovolemia and Diuretic Toxicity, run by Hopital Louis Pradel at 1 site in France.
Trial summary
Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Hypovolemia, Diuretic Toxicity, Fluid Overload
- What is being tested?
- Abdominal compression (AC) and blood sample
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2017to Dec 2019
- 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
- Child
Study population: Pediatric patients under 8 years old, hospitalized in the pediatric intensive care unit of investigation center.
Who may be able to join
- Height year old or less
- Patient hospitalized in the pediatric intensive care unit of the investigation center.
- presenting symptoms of fluid overload characterized with:
- Peripheral edema.
- An increase of 10% between the first day in ICU and inclusion date
- the attending physician should have decided to evaluate hemodynamic with iterative echocardiography
- the attending physician, who is not the investigator has decided to administer diuretics
Who cannot join
- Patient or Holder of parental authority refusal to participate
- Dehydration with natremia over 150 mmol/L or clinical signs of dehydration
- Suspected abdominal hypertension
- recent abdominal surgery with abdominal pain induced by abdominal examination.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Louis Pradel
Bron, Auvergne-Rhône-Alpes, 69100
Matthias Jacquet-Lagrèze, M.D., M.Sc., + 33 6 89 10 99 59, matthias.jl@gmail.com
Jean-Luc Fellahi, M.D., pH.D., +33 4 72 11 89 33, matthias.jl@gmail.com
About this study
Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency. Another point is that during depletion refilling can occur. We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion
Read the detailed description
Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). The pediatric intensivist has a priority to decrease unnecessary fluid load and to make the fluid balance negative in case of fluid overload. Diuretics help to make the fluid balance negative but can lead to a reduction of volemia that can lead to hypovolemia. Hypovolemia can induce a reduction of stroke volume and cardiac index that can alter tissue perfusion and increase organ dysfunction.
It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion.
The concept of preload dependency described by frank-starling is interesting in that context.
Preload dependency is a state of the working heart characterized by a modification of stroke volume when a modification of preload is done. Conversely, no preload dependency is a state of the working heart characterized by no modification of stroke volume when a modification of preload is done.
If the heart is in a state of preload dependency, a reduction of preload induced by diuretics depletion might induce a reduction of stroke volume. Conversely, if the heart is in a state of no preload dependency a reduction of preload induced by a diuretics depletion might not induce a reduction of stroke volume Abdominal compression coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency.
Another point is that during depletion refilling can occur. Studies performed during hemodialysis have shown that refilling maintains a stable hematocrit during depletion. the absence of refilling is characterized by an hemoconcentration
We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic induced depletion of 10ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion
- Conditions
- Hypovolemia, Diuretic Toxicity, Fluid Overload
- Being tested
- Abdominal compression (AC), blood sample
- Medical subject headings
- Hypovolemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal compression (AC)Diagnostic test
Also called Echocardiographic assessement of volume status
An echocardiography with stroke volume measurement coupled with an abdominal compression will be performed before and after ta diuretics induced diuresis of 10ml/kg in pediatric patients hospitalized in a pediatric intensive care unit (PICU) diagnosed with fluid overload
blood sampleDiagnostic test
proteinemia and hematocrit will be measured before and after a diuretics induced diuresis of 10ml/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume index (SVi) variation induced by abdominal compression ΔSVi-AC
Variation of stroke volume index measured with echocardiography induced by abdominal compression. We will test if stroke volume index variation during abdominal compression can predict a decrease of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
Measured: 2 hours
Secondary outcomes (4)
Hemoconcentration with protides
proteinemia variation. We will test if proteinemia variation can predict a diagnose a reduction of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
Measured: 2 hours
Hemoconcentration with hematocrit
Hematocrit variation. We will test if hematocrit variation can predict a diagnose a reduction of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
Measured: 2 hours
Respiratory variation of the maximum aortic velocity of the left ventricular outflow tractΔVpeak
Variation of the maximum velocity of the left ventricular outflow tract induced by ventilation. We will test if ΔVpeak can predict a decrease of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
Measured: 2 hours
Respiratory variation of the inferior vena cava diameter ΔIVC
Variation of inferior vena cava diameter induced by ventilation. We will test if ΔIVC can predict a decrease of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start10 May 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Louis Pradel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Jacquet-Lagrèze, Hopital Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145935
- Sponsor's protocol ID
- ANSM 2017-A01334-49.
- Status last verified
- Apr 2019
- First submitted
- 5 May 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foland JA, Fortenberry JD, Warshaw BL, Pettignano R, Merritt RK, Heard ML, Rogers K, Reid C, Tanner AJ, Easley KA. Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis. Crit Care Med. 2004 Aug;32(8):1771-6. doi: 10.1097/01.ccm.0000132897.52737.49.
PubMed 15286557Sinitsky L, Walls D, Nadel S, Inwald DP. Fluid overload at 48 hours is associated with respiratory morbidity but not mortality in a general PICU: retrospective cohort study. Pediatr Crit Care Med. 2015 Mar;16(3):205-9. doi: 10.1097/PCC.0000000000000318.
PubMed 25581632Li Y, Wang J, Bai Z, Chen J, Wang X, Pan J, Li X, Feng X. Early fluid overload is associated with acute kidney injury and PICU mortality in critically ill children. Eur J Pediatr. 2016 Jan;175(1):39-48. doi: 10.1007/s00431-015-2592-7. Epub 2015 Jul 24.
PubMed 26206387Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.
PubMed 27207178
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.
- ClinicalTrials.gov ID
- NCT03145935
- Acronym / sponsor ID
- ANSM 2017-A01334-49.
- Conditions
- Hypovolemia, Diuretic Toxicity, Fluid Overload
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hopital Louis PradelUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 May 2017 (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.
Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency. Another point is that during depletion refilling can occur. We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion
Detailed description
Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). The pediatric intensivist has a priority to decrease unnecessary fluid load and to make the fluid balance negative in case of fluid overload. Diuretics help to make the fluid balance negative but can lead to a reduction of volemia that can lead to hypovolemia. Hypovolemia can induce a reduction of stroke volume and cardiac index that can alter tissue perfusion and increase organ dysfunction.
It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion.
The concept of preload dependency described by frank-starling is interesting in that context.
Preload dependency is a state of the working heart characterized by a modification of stroke volume when a modification of preload is done. Conversely, no preload dependency is a state of the working heart characterized by no modification of stroke volume when a modification of preload is done.
If the heart is in a state of preload dependency, a reduction of preload induced by diuretics depletion might induce a reduction of stroke volume. Conversely, if the heart is in a state of no preload dependency a reduction of preload induced by a diuretics depletion might not induce a reduction of stroke volume Abdominal compression coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency.
Another point is that during depletion refilling can occur. Studies performed during hemodialysis have shown that refilling maintains a stable hematocrit during depletion. the absence of refilling is characterized by an hemoconcentration
We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic induced depletion of 10ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients under 8 years old, hospitalized in the pediatric intensive care unit of investigation center.
Key inclusion criteria (7 listed)
- Height year old or less
- Patient hospitalized in the pediatric intensive care unit of the investigation center.
- Peripheral edema.
- An increase of 10% between the first day in ICU and inclusion date
Key exclusion criteria (4 listed)
- Patient or Holder of parental authority refusal to participate
- Dehydration with natremia over 150 mmol/L or clinical signs of dehydration
- Suspected abdominal hypertension
- recent abdominal surgery with abdominal pain induced by abdominal examination.
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 |
|---|---|---|
| Abdominal compression (AC)Also: Echocardiographic assessement of volume statusAn echocardiography with stroke volume measurement coupled with an abdominal compression will be performed before and after ta diuretics induced diuresis of 10ml/kg in pediatric patients hospitalized in a pediatric intensive care unit (PICU) diagnosed with fluid overload | Diagnostic test | – |
| blood sampleproteinemia and hematocrit will be measured before and after a diuretics induced diuresis of 10ml/kg | Diagnostic test | – |
Primary outcome
Stroke volume index (SVi) variation induced by abdominal compression ΔSVi-AC
Time frame: 2 hours
Variation of stroke volume index measured with echocardiography induced by abdominal compression. We will test if stroke volume index variation during abdominal compression can predict a decrease of 15 % of the stroke volume during a 10 ml/kg diuresis induced by diuretics administration.
4 secondary outcomes
Hemoconcentration with protides
Time frame: 2 hours
Hemoconcentration with hematocrit
Time frame: 2 hours
Respiratory variation of the maximum aortic velocity of the left ventricular outflow tractΔVpeak
Time frame: 2 hours
Respiratory variation of the inferior vena cava diameter ΔIVC
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Results publication: PubMed 15286557Foland JA, Fortenberry JD, Warshaw BL, Pettignano R, Merritt RK, Heard ML, Rogers K, Reid C, Tanner AJ, Easley KA. Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis. Crit Care Med. 2004 Aug;32(8):1771-6. doi: 10.1097/01.ccm.0000132897.52737.49.
- Results publication: PubMed 25581632Sinitsky L, Walls D, Nadel S, Inwald DP. Fluid overload at 48 hours is associated with respiratory morbidity but not mortality in a general PICU: retrospective cohort study. Pediatr Crit Care Med. 2015 Mar;16(3):205-9. doi: 10.1097/PCC.0000000000000318.
- Results publication: PubMed 26206387Li Y, Wang J, Bai Z, Chen J, Wang X, Pan J, Li X, Feng X. Early fluid overload is associated with acute kidney injury and PICU mortality in critically ill children. Eur J Pediatr. 2016 Jan;175(1):39-48. doi: 10.1007/s00431-015-2592-7. Epub 2015 Jul 24.
- Results publication: PubMed 27207178Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.
- Individual participant dataSharing planned: Undecided
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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.
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 Diuretic Toxicity, run by Hopital Louis Pradel 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 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Jacquet-Lagreze, M.D., M.Sc. (+33 6 89 10 99 59, matthias.jl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume index (SVi) variation induced by abdominal compression ΔSVi-AC (time frame: 2 hours). 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 NCT03145935, which also lists 4 linked publications.
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 12 Apr 2019.