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Respiratory Variations For Predicting Fluid Responsiveness 2 (ReVaPreF2)

Primary Purpose

Sepsis, Circulatory Failure, Respiratory Physiological Phenomena

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 vena cava, fluid, sepsis, echocardiography, ultrasound, ultrasonography, collapsibility index, circulatory failure, irregular cardiac rhythm, fluid responsiveness, Spontaneous breathing

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 Valencienne general hospital.
  • Age greater than or equal to 18.
  • Patient insured
  • Spontaneous breathing without ventilatory support or intubation or tracheotomy.
  • Irregular 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
  • regular cardiac rhythm

Sites / Locations

  • Intensive Care Department, Salengro Hospital,CHRU

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

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
NCT03066375
Brief Title
Respiratory Variations For Predicting Fluid Responsiveness 2
Acronym
ReVaPreF2
Official Title
Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis, Acute Circulatory Failure, and Irregular Cardiac Rhythm
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (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
Objectives: To investigate whether respiratory variations of inferior vena cava diameters (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute circulatory failure and irregular heartbeats. Design: Prospective, bicentric study, intensive care units. Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of acute circulatory failure are included. A positive response to fluid loading (FL) is defined as an increase of the stroke volume (SV) >10%. The investigators measured the minimum inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before a 500ml-colloid FL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Circulatory Failure, Respiratory Physiological Phenomena
Keywords
vena cava, fluid, sepsis, echocardiography, ultrasound, ultrasonography, collapsibility index, circulatory failure, irregular cardiac rhythm, fluid responsiveness, Spontaneous breathing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (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
Device
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

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 Valencienne general hospital. Age greater than or equal to 18. Patient insured Spontaneous breathing without ventilatory support or intubation or tracheotomy. Irregular 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 regular 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,CHRU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Respiratory Variations For Predicting Fluid Responsiveness 2

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