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

NCT03145935 | Unknown

• 1 other identifier: ANSM 2017-A01334-49.
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypovolemia; Diuretic Toxicity; Fluid Overload

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hemoconcentration with protides

  2 hours

• Hemoconcentration with hematocrit

  2 hours

• Respiratory variation of the maximum aortic velocity of the left ventricular outflow tractΔVpeak

  2 hours

• Respiratory variation of the inferior vena cava diameter ΔIVC

  2 hours

Interventions

Abdominal compression (AC) DIAGNOSTIC_TEST

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

Also known as: Echocardiographic assessement of volume status

blood sample DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients under 8 years old, hospitalized in the pediatric intensive care unit of investigation center.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Louis Pradel: lead

Study Sites (1)

Hopital Louis Pradel

Bron, Auvergne-Rhône-Alpes, 69100, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 15286557 RESULT

• 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.

  PMID: 25581632 RESULT

• 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.

  PMID: 26206387 RESULT

• 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.

  PMID: 27207178 RESULT

MeSH Terms

Conditions

Hypovolemia; Edema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

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

CONTACT

+33 6 89 10 99 59; matthias.jl@gmail.com

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

CONTACT

+33 4 72 11 89 33; jean-luc.fellahi@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal investigator

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 10, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

FR (1)