Respiratory Variations For Predicting Fluid Responsiveness 2

NCT03066375 | Completed DMC

• 2 other identifiers: 2011_462011-A01598-33
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Circulatory Failure; Respiratory Physiological Phenomena

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Echocardiography-Doppler

EXPERIMENTAL

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.

Device: Echocardiography-Doppler

Interventions

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.

Echocardiography-Doppler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Intensive Care Department, Salengro Hospital,CHRU

Lille, France

Location

MeSH Terms

Conditions

Sepsis; Shock

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Sebastien Preau, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: February 28, 2017
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)