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

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.

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Key information

Conditions

Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care and anesthesiology department, Hôpital Louis Pradel., Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age < 8 years old
Patient with a circulatory failure defined as follow :

Treatment including vasopressor or inotrope

OR macrocirculatory failure

Heart rate > 2 Standard Deviation (SD)
Systolic arterial pressure < 2 SD
Mean arterial pressure < 2 SD
Diastolic arterial pressure < 2 SD

WITH signs of microcirculatory failure

Capillary refill time > 2 secondes
Blotch
Organ dysfunction due to the circulatory failure (Oliguria < 0,5 ml/kg/h, acute lung injury, encephalopathy)

Exclusion criteria

Opposition from the parents or the one who holds the parental authority
Cardiogenic acute pulmonary edema,
Extreme hemodynamic instability,
Intra-abdominal hypertension,
Recent abdominal surgery that does not permit an abdominal compression without causing pain.
Patient with mechanical circulatory support, such as Extra Corporal Life Support or Berlin-Heart
Patient with congenital cardiopathy with a palliative correction or an incomplete correction
Open thorax
Prone position
Investigators not available
No security number registration.
Moribund patient

Treatment and study plan

Observational study. No special intervention will be made

Other

Data 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.

Primary outcomes

Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness

Time frame: 30 minutes

Stroke volume will be measured before and after a calibrated abdominal compression and after a fluid load. Patient will then be sorted in two groups. Responders defined as patient that show an increase in stroke volume after a 10ml/kg fluid load and Fluid non responders, defined as patient that show an increase of less than 15 % in stroke volume. The ROC curve will investigate the ability of stroke volume variation after abdominal compression to predict fluid responsiveness.

Secondary outcomes

Ability of the pulse pressure variation after abdominal compression to predict fluid responsiveness

Time frame: 30 minutes
Ability of the heart rate variation after abdominal compression to predict fluid responsiveness

Time frame: 30 minutes
Correlation between stroke volume variation, heart rate variation, pulse pressure variation between the abdominal compression and the fluid load

Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Hopital Louis Pradel

Other

Registry information

Acronym: FRANCK

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jul 22, 2015
Registry last updated: Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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