Respiratory Variations For Predicting Fluid Responsiveness 2

Not Applicable

Completed

• Conditions: Respiratory Physiological Phenomena; Sepsis; Circulatory Failure
• Interventions: Device: Echocardiography-Doppler

• Registration Number: NCT03066375
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Study First Submitted: 2016-11-09
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echocardiography-Doppler	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Intensive Care Department, Salengro Hospital,CHRU; 🇫🇷 Lille, France