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

Circulatory Failure Clinical Trial

— FRANCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505646
• Other study ID #: EudraCT/ANSM 2015-A00388-41
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: December 25, 2016
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Hopital Louis Pradel
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Circulatory Failure
• Shock

Intervention

Other:
• Observational study. No special intervention will be made
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.

Locations

Country	Name	City	State
France	Intensive care and anesthesiology department, Hôpital Louis Pradel.	Lyon
France	Pediatric Intensive care, Hôpital Femme Mère Enfant	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Louis Pradel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the stroke volume variation after abdominal compression to predict fluid responsiveness	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.	30 minutes	No
Secondary	Ability of the pulse pressure variation after abdominal compression to predict fluid responsiveness		30 minutes	No
Secondary	Ability of the heart rate variation after abdominal compression to predict fluid responsiveness		30 minutes	No
Secondary	Correlation between stroke volume variation, heart rate variation, pulse pressure variation between the abdominal compression and the fluid load		30 minutes	No