Respiratory Variations For Predicting Fluid Responsiveness 2

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03066375

Acronym

ReVaPreF2

Enrollment

Registered

2017-02-28

Start date

2012-05-31

Completion date

2015-06-30

Last updated

2017-02-28

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

Conditions

Circulatory Failure, Respiratory Physiological Phenomena, Sepsis

Keywords

vena cava, fluid, sepsis, echocardiography, ultrasound, ultrasonography, collapsibility index, circulatory failure, irregular cardiac rhythm, fluid responsiveness, Spontaneous breathing

Brief summary

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.

Interventions

DEVICEEchocardiography-Doppler

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

France

Outcome results

None listed

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