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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Shock; Circulatory Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01590511

LOCAL/2012/XB-02

2012-A00500-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

71 participants in 1 patient group

The study population

Description:

Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.