Respiratory Variations for Predicting Fluid Responsiveness

NCT03066362 | Completed DMC

• 2 other identifiers: 2011_102011-A00990-41
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

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

Secondary Outcomes (1)

• "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

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.

Other: Echocardiography-Doppler

Interventions

Echocardiography-Doppler 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.

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 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

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
• Irregular cardiac rhythm

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Intensive Care Department, Salengro Hospital, CHU de Lille

Lille, Hauts-de-France, 59000, France

Location

Related Publications (1)

• Bortolotti P, Colling D, Colas V, Voisin B, Dewavrin F, Poissy J, Girardie P, Kyheng M, Saulnier F, Favory R, Preau S. Respiratory changes of the inferior vena cava diameter predict fluid responsiveness in spontaneously breathing patients with cardiac arrhythmias. Ann Intensive Care. 2018 Aug 2;8(1):79. doi: 10.1186/s13613-018-0427-1.

  PMID: 30073423 RESULT

MeSH Terms

Conditions

Sepsis; Shock

Condition Hierarchy (Ancestors)

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

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: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 22, 2026

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)