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

• Conditions: Diuretic Toxicity; Hypovolemia; Fluid Overload

• Registration Number: NCT03145935
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-05-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke volume index (SVi) variation induced by abdominal compression ΔSVi-AC	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

Name	Time	Method
Hemoconcentration with protides	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.
Hemoconcentration with hematocrit	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.
Respiratory variation of the maximum aortic velocity of the left ventricular outflow tractΔVpeak	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.
Respiratory variation of the inferior vena cava diameter ΔIVC	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.

Trial Locations

Locations (1)

Hopital Louis Pradel; 🇫🇷 Bron, Rhone Alpes, France