Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR
Primary Purpose
Arrhythmia Atrial
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preload assessment and volume expansion
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia Atrial
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients in the units of Surgical ICU and Cardiothoracic ICU of the Universatory Hospital of Poitiers
- With atrial Fibrillation
- With spontaneous ventilation
- With acute circulatory failure and medical decision to fluid therapy (Systolic Arterial Blood Pressure < 90 mmHg and/or vasopressors agents)
- With no left or right ventricular dysfunction
Exclusion Criteria:
- Patients < 18 yrs
- Contraindictions to passive leg rising
- Clinical evidence of hemorrhagic shock
- Cardiogenic shock
- Necessity of fluid expansion in emergency
- No echographic windows
Sites / Locations
- CHU de Poitiers
Outcomes
Primary Outcome Measures
Evaluation of the diagnostic performance of the index deltaI ITV / delta RR
Increase of 15% or more of stroke volume after fluid therapy
Secondary Outcome Measures
Diagnostic performances of passive leg rising for prediction of fluid responsiveness
Diagnostic performances of respiratory variations of inferior vena cava for prediction of fluid responsiveness
Full Information
NCT ID
NCT03461094
First Posted
February 22, 2018
Last Updated
June 12, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03461094
Brief Title
Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR
Official Title
Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fluid therapy is often used as first line treatment of acute circulatory failure, aiming an increase in cardiac output (by improving preload) and in tissue perfusion. Depending on left ventricular systolic function, fluid challenge could lead to an increase in cardiac ouput and tissue perfusion, or only detrimental consequences (by fluid overload and aggravation of lung and tissues oedema, increase of morbi-mortality). Patients are defined as responders to fluid therapy if one can observe an increase of cardiac output up to 15% after fluid therapy (500ml of crystalloids): gold standard test used in most of the studies on the subject. Literature reports on heterogenous populations a reproductible and constant response rate to this fluid challenge of 50%. It seems reasonable to dispose of indices allowing to predict fluid responsiveness without resulting in fluid intake. Statics markers have been abandonned for several years and dynamics methods have been developped.
In front of arrythmia, validated methods are scarce. Passive leg rising method appears to be the only one and it's validity seems to be less well documented than in sinusal patients. The purpose of this study is to determine a new method to assess fluid responsiveness in arrythmic patients.
In atrial fibrillation, RR interval varies widely between cardiac cylces. Systolic interval remain constant. Variations will occure at expense of diastolic interval, or ventricular filling interval. One can reliably assume that when RR is longer, preload is rising. If the patient is on the ascendant part of the Franck-Starling curve, a longer RR should cause au greater VTI (Vitess Time Integral, surrogate of cardiac output).
The evaluation by transthoracic echocardiography of the indice delta ITV / delta RR should determine the degree of fluid responsiveness in arrhythmic patients.
After decision of fluid expansion, patients will have haemodynamic and echocardiographic data measured, delta ITV / delta RR indice assessed, then passive leg rising and fluid expansion with 500 ml of cristalloids administered, with evaluation of VTI (as surrogate of cardiac output) at each time. Fluid responders will be compared to non-responders to evaluate the diagnostic performances of the indice delta ITV / delta RR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia Atrial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Preload assessment and volume expansion
Intervention Description
Fluid therapy perform
Primary Outcome Measure Information:
Title
Evaluation of the diagnostic performance of the index deltaI ITV / delta RR
Description
Increase of 15% or more of stroke volume after fluid therapy
Time Frame
Fluid therapy taking 20 minutes, with responsiveness evaluation within the 5 minutes following fluid therapy
Secondary Outcome Measure Information:
Title
Diagnostic performances of passive leg rising for prediction of fluid responsiveness
Time Frame
Fluid therapy taking 20 minutes, with responsiveness evaluation within the 5 minutes following fluid therapy
Title
Diagnostic performances of respiratory variations of inferior vena cava for prediction of fluid responsiveness
Time Frame
Fluid therapy taking 20 minutes, with responsiveness evaluation within the 5 minutes following fluid therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients in the units of Surgical ICU and Cardiothoracic ICU of the Universatory Hospital of Poitiers
With atrial Fibrillation
With spontaneous ventilation
With acute circulatory failure and medical decision to fluid therapy (Systolic Arterial Blood Pressure < 90 mmHg and/or vasopressors agents)
With no left or right ventricular dysfunction
Exclusion Criteria:
Patients < 18 yrs
Contraindictions to passive leg rising
Clinical evidence of hemorrhagic shock
Cardiogenic shock
Necessity of fluid expansion in emergency
No echographic windows
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kerforne
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR
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