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

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

Study Overview

• Status: Unknown
• Conditions: Fluid Overload; Hypovolemia; Diuretic Toxicity
• Intervention / Treatment: 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
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Bron, Rhone Alpes, France, 69100
      • Recruiting
      • Hôpital Louis Pradel
      • Contact: Matthias Jacquet-Lagrèze, M.D., M.Sc.; Phone Number: + 33 6 89 10 99 59; Email: matthias.jl@gmail.com
      • Contact: Jean-Luc Fellahi, M.D., pH.D.; Phone Number: +33 4 72 11 89 33; Email: matthias.jl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 hours

Collaborators and Investigators

• Sponsor: Hopital Louis Pradel

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: ANSM 2017-A01334-49.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No