Ultrasound Optimization of Initial Fluid Challenge in Sepsis

• Conditions: Sepsis

• Registration Number: NCT04028102
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-10-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
concordance of fluid volume	3 hours after FC initiation	number of patients with delta FC volume \> 20% between US technique and the theoretical 30 ml/kg

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France