Respiratory Variations for Predicting Fluid Responsiveness

Not Applicable

Completed

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

• Registration Number: NCT03066362
• Lead Sponsor: University Hospital, Lille

Brief Summary

Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is the first treatment improve circulatory function. However, too much VE can be harmful. So, the use of dynamic predictive indicators of fluid responsiveness is recommended in patients with sepsis.In patients with spontaneous ventilation, few studies have evaluated these parameters. In mechanical ventilation, indices based on the respiratory variation of the diameters of vena cava have been studied and validated to predict the response to VE. However there is no similar study in spontaneously breathing patients without ventilatory support. The investigators hypothesize that the respiratory variations in the IVC diameters and femoral artery flow during standardized respiratory cycles are predictive factors of fluid responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure, and regular cardiac rhythm.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2014-01
• Study Completion: 2014-02
• 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: 90

Inclusion Criteria

• Adult patients of the intensive care units of the Lille university-hospital and of the Valenciennes general hospital.

• Age greater than or equal to 18.

• Patient insured

• Spontaneous breathing without ventilatory support or intubation or tracheotomy.

• Regular 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
• Irregular 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

Secondary Outcome Measures

Name	Time	Method
"respiratory variations the femoral artery flow" 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, CHU de Lille; 🇫🇷 Lille, Nord-Pas-de-Calais, France