Clinical trial NCT03066375: Respiratory Variations For Predicting Fluid Responsiveness 2
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Circulatory Failure
Respiratory Physiological Phenomena
Keywords: vena cava
fluid
sepsis
echocardiography
ultrasound
ultrasonography
collapsibility index
circulatory failure
irregular cardiac rhythm
fluid responsiveness
Spontaneous breathing
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve
timeFrame: during 30 minutes of the volume expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Intensive Care Department, Salengro Hospital,CHRU
Study officials:
affiliation: University Hospital, Lille
name: Sebastien Preau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: