Respiratory Variations For Predicting Fluid Responsiveness 2

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.

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Key information

Conditions

Sepsis Circulatory Failure Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Physiological Phenomena Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Department, Salengro Hospital,CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography-Doppler

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: ReVaPreF2

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 28, 2017
Registry last updated: Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed