ReVaPreF2: Respiratory Variations For Predicting Fluid Responsiveness 2

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03066375

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Circulatory Failure Respiratory Physiological Phenomena	Device: Echocardiography-Doppler	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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