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NCT Number: NCT03066362

Respiratory Variations for Predicting Fluid Responsiveness

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.

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Key information

Conditions

Sepsis Circulatory Failure Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Physiological Phenomena Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Department, Salengro Hospital, CHU de Lille

Lille, Hauts-de-France, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography-Doppler

Other

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.

Primary outcomes

"respiratory variations in inferior vena cava diameters" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve

Time frame: during 30 minutes of the volume expansion

Secondary outcomes

"respiratory variations the femoral artery flow" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve

Time frame: during 30 minutes of the volume expansion

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: ReVaPreF

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Feb 28, 2017
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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