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

NCT ID: NCT03145935

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Hypovolemia Diuretic Toxicity Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

blood sample

proteinemia and hematocrit will be measured before and after a diuretics induced diuresis of 10ml/kg

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Echocardiographic assessement of volume status

Eligibility Criteria

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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.
Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Louis Pradel

OTHER

Sponsor Role lead

Responsible Party

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Matthias Jacquet-Lagrèze

Medical doctor, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopital Louis Pradel

Bron, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Matthias Jacquet-Lagreze, M.D., M.Sc.

Role: CONTACT

+33 6 89 10 99 59

Jean-Luc Fellahi, M.D.,Ph.D.

Role: CONTACT

+33 4 72 11 89 33

Facility Contacts

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Matthias Jacquet-Lagrèze, M.D., M.Sc.

Role: primary

+ 33 6 89 10 99 59

Jean-Luc Fellahi, M.D., pH.D.

Role: backup

+33 4 72 11 89 33

References

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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.

Reference Type RESULT
PMID: 15286557 (View on PubMed)

Sinitsky 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.

Reference Type RESULT
PMID: 25581632 (View on PubMed)

Li 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.

Reference Type RESULT
PMID: 26206387 (View on PubMed)

Monnet 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.

Reference Type RESULT
PMID: 27207178 (View on PubMed)

Other Identifiers

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ANSM 2017-A01334-49.

Identifier Type: -

Identifier Source: org_study_id

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