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Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.

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ClinicalTrials.gov Identifier: NCT03145935
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Jacquet-Lagrèze, Hopital Louis Pradel

Brief 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. 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

Condition or disease Intervention/treatment
Hypovolemia Diuretic Toxicity Fluid Overload Diagnostic Test: Abdominal compression (AC) Diagnostic Test: blood sample

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 Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Intervention Details:
  • Diagnostic Test: Abdominal compression (AC)
    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
    Other Name: Echocardiographic assessement of volume status
  • Diagnostic Test: blood sample
    proteinemia and hematocrit will be measured before and after a diuretics induced diuresis of 10ml/kg


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hemoconcentration with protides [ Time Frame: 2 hours ]
    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.

  2. Hemoconcentration with hematocrit [ Time Frame: 2 hours ]
    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.

  3. Respiratory variation of the maximum aortic velocity of the left ventricular outflow tractΔVpeak [ Time Frame: 2 hours ]
    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.

  4. Respiratory variation of the inferior vena cava diameter ΔIVC [ Time Frame: 2 hours ]
    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.



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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients under 8 years old, hospitalized in the pediatric intensive care unit of investigation center.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145935


Contacts
Contact: Matthias Jacquet-Lagreze, M.D., M.Sc. +33 6 89 10 99 59 matthias.jl@gmail.com
Contact: Jean-Luc Fellahi, M.D.,Ph.D. +33 4 72 11 89 33 jean-luc.fellahi@chu-lyon.fr

Locations
France
Hopital Louis Pradel Recruiting
Bron, Rhone Alpes, France, 69100
Contact: Matthias Jacquet-Lagrèze, M.D., M.Sc.    + 33 6 89 10 99 59    matthias.jl@gmail.com   
Contact: Jean-Luc Fellahi, M.D., pH.D.    +33 4 72 11 89 33    matthias.jl@gmail.com   
Sponsors and Collaborators
Hopital Louis Pradel

Publications of Results:
Responsible Party: Matthias Jacquet-Lagrèze, Medical doctor, Principal investigator, Hopital Louis Pradel
ClinicalTrials.gov Identifier: NCT03145935     History of Changes
Other Study ID Numbers: ANSM 2017-A01334-49.
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes
Diuretics
Natriuretic Agents
Physiological Effects of Drugs