Clinical trial NCT01590511: Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
Official title: Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Circulatory Failure
Keywords: mini fluid challenge
subaortic velocity time integral
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)
timeFrame: baseline; 26 minutes
Secondary outcomes:
measure: Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)
timeFrame: baseline; 15 minutes
measure: Change in heart rate after the "mini-fluid challenge"
timeFrame: baseline; 26 minutes
measure: Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)
timeFrame: baseline; 26 minutes
measure: Change in mitral E wave (cm / s) after the "mini-fluid challenge"
timeFrame: baseline; 26 minutes
measure: Change in the E/A ratio after the "mini-fluid challenge"
timeFrame: baseline; 26 minutes
measure: Change in the Marbrure clinical score after the "mini-fluid challenge"
timeFrame: baseline; 26 minutes
measure: Change in lower vena cava diameter
timeFrame: baseline; 8 minutes
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Xavier Bobbia, MD
role: PRINCIPAL_INVESTIGATOR
References: