Respiratory Variations For Predicting Fluid Responsiveness 2

Study Overview
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Brief Summary
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Objectives: To investigate whether respiratory variations of inferior vena cava diameters (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute circulatory failure and irregular heartbeats. Design: Prospective, bicentric study, intensive care units. Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of acute circulatory failure are included. A positive response to fluid loading (FL) is defined as an increase of the stroke volume (SV) >10%. The investigators measured the minimum inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before a 500ml-colloid FL.

Official Title
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Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis, Acute Circulatory Failure, and Irregular Cardiac Rhythm

Conditions
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Sepsis, Circulatory Failure, Respiratory Physiological Phenomena

Intervention / Treatment
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* Device: Echocardiography-Doppler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of the intensive care units of the Lille university-hospital and of the Valencienne general hospital. Age greater than or equal to 18. Patient insured Spontaneous breathing without ventilatory support or intubation or tracheotomy. Irregular cardiac rhythm Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes. Patients with sepsis with at least one sign of acute circulatory failure: Tachycardia with heart rate> 100/min systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient Oliguria <0.5ml/kg/hour for at least one hour skin mottling Exclusion Criteria: high-grade aortic insufficiency transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters clinical signs of active exhalation clinical or ultrasonographic evidence of pulmonary edema due to heart failure pregnancy abdominal compartment syndrome regular cardiac rhythm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echocardiography-Doppler<br>Ultrasonographic recordings, systemic arterial pressure, heart rate, and respiratory rate are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles. | Device: Echocardiography-Doppler<br>* Ultrasonographic recordings are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve |  | during 30 minutes of the volume expansion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vena cava, fluid, sepsis, echocardiography, ultrasound, ultrasonography, collapsibility index, circulatory failure, irregular cardiac rhythm, fluid responsiveness, Spontaneous breathing