Respiratory Variations For Predicting Fluid Responsiveness 2

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066375
• Other study ID #: 2011_46
• Secondary ID: 2011-A01598-33
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: February 27, 2017
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulatory Failure
• Respiratory Physiological Phenomena
• Sepsis
• Shock

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Intensive Care Department, Salengro Hospital,CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve		during 30 minutes of the volume expansion