Sepsis MedDRA version: 20.0 Level: LLT Classification code 10040050 Term: Sepsis NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Soidum chloride solution 0.9%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: % (
Sponsors
Marie Kristine Jessen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes will be • Feasibility measures: o Number of patients with major protocol violations, o Number of patients screened vs included o Time from admission to inclusion o Number of patients lost to follow up in terms of 24-hour fluids (e.g. due to discharge within 24 hours) o Accumulated serious adverse reactions and events (SAEs (cerebral, cardiac, intestinal or limb ischemia or a new episode of kidney failure (modified KDIGO3)) + SARs (seizures, anafylactic reaction, central pontine myelinose, hypernatriemia, hyperchloremia, severe metabolic alkalosis) + SUSARs) within 7 days in-hospital • Total fluids (oral and intravenous) at 24 hours We will also report in-hospital mortality and 30- and 90-day mortality (possible outcomes for the final large scale trial), in-hospital length of stay (LOS), mechanical ventilation within 7 days of admission (yes/no), vasopressor use within 7 days of admission (yes/no), and development or worsening of acute kidney failure according to the KDIGO3-criteria within 7 days of admission . ;Timepoint(s) of evaluation of this end point: 24 hours, 7-days and 30+90-day mortality + their entire in-hospital stay | — |
Countries
Denmark
Contacts
Public ContactResearch Center for Emergency Medic
Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University
Outcome results
None listed