Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

Shock Clinical Trial

— IVT NonVent  

Official title:

Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590511
• Other study ID #: LOCAL/2012/XB-02
• Secondary ID: 2012-A00500-43
• Status: Completed
• Phase: N/A
• First received: April 30, 2012
• Last updated: December 3, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

Description:

The secondary objectives of this study include:

• To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.

• To study the inter-observer variation of ΔITV100 measurement.

• To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• Systolic blood pressure (SBP) < 90 mmHg

• Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia

• Requires amines to maintain an SBP = 90 mmHg or inability to lower amines or requires an increase in amines

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• The patient (or his/her person-of-trust) refuses to sign the consent

• It is impossible to correctly inform the patient

• The patient is pregnant, parturient, or breastfeeding

• The patients has a contraindication for a treatment necessary for this study

• Cardiogenic shock

• Acute pulmonary edema

• Moribund patient

• Non echogenic patient

• Patient with cardiac arrhythmia

• Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Circulatory Failure
• Shock

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)		baseline; 26 minutes	No
Secondary	Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)		baseline; 15 minutes	No
Secondary	Change in heart rate after the "mini-fluid challenge"	(bpm,%)	baseline; 26 minutes	No
Secondary	Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)		baseline; 26 minutes	No
Secondary	Change in mitral E wave (cm / s) after the "mini-fluid challenge"		baseline; 26 minutes	No
Secondary	Change in the E/A ratio after the "mini-fluid challenge"		baseline; 26 minutes	No
Secondary	Change in the Marbrure clinical score after the "mini-fluid challenge"		baseline; 26 minutes	No
Secondary	Change in lower vena cava diameter	(DiameterMax-DiameterMin) / DiameterMax (cm;%)	baseline; 8 minutes	No