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Respiratory Variations For Predicting Fluid Responsiveness 2

NCT ID: NCT03066375

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Circulatory Failure Respiratory Physiological Phenomena

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Echocardiography-Doppler

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien Preau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Intensive Care Department, Salengro Hospital,CHRU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2011_46

Identifier Type: -

Identifier Source: org_study_id

2011-A01598-33

Identifier Type: OTHER

Identifier Source: secondary_id