Clinical Trials Directory

Trials / Completed

CompletedNCT03461094

Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Poitiers University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPreload assessment and volume expansionFluid therapy perform

Timeline

Start date
2017-05-17
Primary completion
2020-06-12
Completion
2020-06-12
First posted
2018-03-09
Last updated
2020-06-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03461094. Inclusion in this directory is not an endorsement.