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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01590511
Acronym
IVT NonVent
Enrollment
71
Registered
2012-05-03
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory Failure, Shock

Keywords

mini fluid challenge, subaortic velocity time integral

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026