Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial

Phase 1

• Conditions: Sepsis; MedDRA version: 20.0Level: LLTClassification code 10040050Term: Sepsis NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-000224-35-DK
• Lead Sponsor: Marie Kristine Jessen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-03
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

We will include patients fulfilling the following:
1)Unplanned emergency department admission
2)Age = 18 years
3)Sepsis defined as
a) suspected infection by the treating clinician AND
b) blood cultures drawn AND
c) IV antibiotics administered or planned AND
d) An infection related increase of SOFA-score = 2 from baseline
4)Expected hospital stay > 24 hours as deemed by treating clinician

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

We will exclude patients fulfilling any of following exclusion criteria:

1) = 500 ml of fluids given prior to randomization
2) Invasively ventilated or vasopressors initiated at the time of screening
3) Known or suspected severe bleeding judged by the treating clinician
4) Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
5) Prior enrollment in the trial
6) Patients, who the clinician expect not to survive the next 24-hours

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if an IV fluid restrictive protocol in ED patients with sepsis is feasible, i.e., if the protocol decreases the IV fluid volumes administered compared to standard care. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome will be the total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization. (Feasibility measure);Timepoint(s) of evaluation of this end point: 24 hours after enrollment