Respiratory Variations for Predicting Fluid Responsiveness

NCT ID: NCT03066362

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Sepsis; Respiratory Physiological Phenomena; Circulatory Failure

Keywords

Spontaneous ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Echocardiography-Doppler

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastien Preau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Intensive Care Department, Salengro Hospital, CHU de Lille

Lille, Hauts-de-France, France

Countries

France

Other Identifiers

2011-A00990-41

Identifier Type: OTHER

Identifier Source: secondary_id

2011_10

Identifier Type: -

Identifier Source: org_study_id