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Respiratory Variations for Predicting Fluid Responsiveness (ReVaPreF)

Primary Purpose

Sepsis, Respiratory Physiological Phenomena, Circulatory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiography-Doppler
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Spontaneous ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Department, Salengro Hospital, CHU de Lille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echocardiography-Doppler

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2016
Last Updated
February 27, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03066362
Brief Title
Respiratory Variations for Predicting Fluid Responsiveness
Acronym
ReVaPreF
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Respiratory Physiological Phenomena, Circulatory Failure
Keywords
Spontaneous ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echocardiography-Doppler
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Echocardiography-Doppler
Intervention Description
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 Outcome Measure Information:
Title
"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 Outcome Measure Information:
Title
"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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Preau, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Department, Salengro Hospital, CHU de Lille
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Respiratory Variations for Predicting Fluid Responsiveness

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