Skip to content

Respiratory Variations for Predicting Fluid Responsiveness

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03066362
Acronym
ReVaPreF
Enrollment
90
Registered
2017-02-28
Start date
2011-11-01
Completion date
2014-02-01
Last updated
2026-04-22

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

Spontaneous ventilation

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.

Interventions

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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frame
"respiratory variations in inferior vena cava diameters" with respect to the response to fluid resuscitation, assessed by the area under the ROC curveduring 30 minutes of the volume expansion

Secondary

MeasureTime frame
"respiratory variations the femoral artery flow" with respect to the response to fluid resuscitation, assessed by the area under the ROC curveduring 30 minutes of the volume expansion

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSebastien Preau, MD, PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026