Ultrasound Optimization of Initial Fluid Challenge in Sepsis (echosepsis)

Optimization of Initial Fluid Challenge by Cardiac and Lung Ultrasound in Patients With Sepsis

Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.

Study Overview

• Status: Unknown
• Conditions: Sepsis

Detailed Description

Initial sepsis treatment requires fluid challenge (FC). While the Surviving Sepsis Campaign (SSC) indicates a fixed 30 ml/kg volume, there is concerns on the efficacy and safety of this volume.

Actually, the required volume is highly dependent of cardiac and pulmonary comorbidities, infection focus localization and intensity. The importance of the initial volume is crucial: if too low, it could not restore the hemodynamic status, if too high, it could induce a lung edema responsible for an increased morbidity and mortality.

Cardiac Ultrasound (US) has demonstrated its efficacy to approach cardiac output by measuring the velocity-time integral (VTI) in the aortic chamber and its variations induced by the FC. While the VTI induced variation by a 500-ml FC in 20 min is above 10%, the patient is still fluid responsiveness and FC has to be continued. Conversely, when the variation is below 10%, FC has to be stopped.

Lung Ultrasound can detect a sub-clinical pulmonary edema before oxygenation degradation by visualization of diffuses B lines. The combination of both techniques is thus able to individualize the actual needed FC volume.

In patients with sepsis as defined by SEPSIS-3 and with hypotension (MAP < 65 mm Hg or lactate > 2 mmol/l), the FC of saline serum is individualized by the US technique. The volume is compared with the fixed 30 ml/kg.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • Nantes university hospital
    • Contact: Philippe Le Conte, Pr; Phone Number: +33 02.40083.934; Email: philippe.leconte@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with sepsis and hypotension in the Emergency Department

Description

Inclusion Criteria:

• patients >18 years old with sepsis as defined by SEPSIS-3 and with hypotension (MAP < 65 mm Hg or lactate > 2 mmol/l)

Exclusion Criteria:

• documented end-of-life
• pregnancy
• B/B initial profile to the first Lung US

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance of fluid volume	number of patients with delta FC volume > 20% between US technique and the theoretical 30 ml/kg	3 hours after FC initiation

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: treatment; sepsis; fluid challenge
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2015-034