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

Completed

• Conditions: Shock; Circulatory Failure

• Registration Number: NCT01590511
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Study Start: 2013-01
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)	baseline; 26 minutes

Secondary Outcome Measures

Name	Time	Method
Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)	baseline; 15 minutes
Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)	baseline; 26 minutes
Change in the E/A ratio after the "mini-fluid challenge"	baseline; 26 minutes
Change in the Marbrure clinical score after the "mini-fluid challenge"	baseline; 26 minutes
Change in lower vena cava diameter	baseline; 8 minutes	(DiameterMax-DiameterMin) / DiameterMax (cm;%)
Change in heart rate after the "mini-fluid challenge"	baseline; 26 minutes	(bpm,%)
Change in mitral E wave (cm / s) after the "mini-fluid challenge"	baseline; 26 minutes

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France