Clinical Trials Directory

Trials / Completed

CompletedNCT02505646

Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Hopital Louis Pradel · Academic / Other
Sex
All
Age
8 Years
Healthy volunteers
Not accepted

Summary

Purpose: Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated. The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure. Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg. Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.

Conditions

Interventions

TypeNameDescription
OTHERObservational study. No special intervention will be madeData will be recorded in a context of fluid load in a context of circulatory failure. Stroke volume will be monitored, before, after an abdominal compression and after a fluid load.

Timeline

Start date
2015-07-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2015-07-22
Last updated
2016-12-28

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02505646. Inclusion in this directory is not an endorsement.