Clinical trial NCT03066362: Respiratory Variations for Predicting Fluid Responsiveness
Official title: Respiratory Variations of the Inferior Vena Cava and Femoral Artery Flow to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis, Acute Circulatory Failure, and Regular Cardiac Rhythm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Respiratory Physiological Phenomena
Circulatory Failure
Keywords: Spontaneous ventilation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 90
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: Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is the first treatment improve circulatory function. However, too much VE can be harmful. So, the use of dynamic predictive indicators of fluid responsiveness is recommended in patients with sepsis.In patients with spontaneous ventilation, few studies have evaluated these parameters. In mechanical ventilation, indices based on the respiratory variation of the diameters of vena cava have been studied and validated to predict the response to VE. However there is no similar study in spontaneously breathing patients without ventilatory support. The investigators hypothesize that the respiratory variations in the IVC diameters and femoral artery flow during standardized respiratory cycles are predictive factors of fluid responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure, and regular cardiac rhythm.


Eligibility criteria: Inclusion Criteria:

* Adult patients of the intensive care units of the Lille university-hospital and of the Valenciennes general hospital.
* Age greater than or equal to 18.
* Patient insured
* Spontaneous breathing without ventilatory support or intubation or tracheotomy.
* Regular 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
* Irregular 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:
measure: "respiratory variations the femoral artery flow" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve
timeFrame: during 30 minutes of the volume expansion
Other outcomes:
Locations:
city: Lille
country: France
facility: Intensive Care Department, Salengro Hospital, CHU de Lille
state: Nord-Pas-de-Calais
Study officials:
affiliation: University Hospital, Lille
name: Sebastien Preau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: