Respiratory Variations for Predicting Fluid Responsiveness (ReVaPreF)

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Circulatory Failure; Respiratory Physiological Phenomena
• Intervention / Treatment: Other: Echocardiography-Doppler

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • Intensive Care Department, Salengro Hospital, CHU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Echocardiography-Doppler; Ultrasonographic recordings, systemic arterial pressure, heart rate, and respiratory rate 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.

Other: Echocardiography-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.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Secondary Outcome Measures

Outcome Measure	Time Frame
"respiratory variations the femoral artery flow" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve	during 30 minutes of the volume expansion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Sebastien Preau, MD, PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Bortolotti P, Colling D, Colas V, Voisin B, Dewavrin F, Poissy J, Girardie P, Kyheng M, Saulnier F, Favory R, Preau S. Respiratory changes of the inferior vena cava diameter predict fluid responsiveness in spontaneously breathing patients with cardiac arrhythmias. Ann Intensive Care. 2018 Aug 2;8(1):79. doi: 10.1186/s13613-018-0427-1.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Spontaneous ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Shock
• Other Study ID Numbers: 2011_10; 2011-A00990-41 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No