Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 12:49 PM
Study NCT ID:
NCT05076435
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2021-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients
Sponsor:
Marie Kristine Jessen, MD
Organization:
Study Overview
Official Title:
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFACED Sepsis
Brief Summary:
This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis allocated to two different IV fluid regimens enrolled at three emergency departments in Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume within 24 hours and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day mortality.
Detailed Description:
BACKGROUND:
Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.
OBJECTIVES:
The aim of the REFACED Sepsis trial is 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.
DESIGN:
REFACED Sepsis is a multicenter, randomized, parallel-group, open-labeled, feasibility trial
POPULATION:
ED patients with sepsis expected to be admitted for ≥ 24 hours
EXPERIMENTAL INTERVENTION:
In the IV fluid restriction group no IV fluids should be given unless one of the below mentioned occurs;
A fluid bolus of 250 ml isotonic crystalloid may be given within 15 minutes if one of the following occurs (hypoperfusion criteria):
* Lactate concentration ≥ 4 mmol/l (arterial or venous blood gas/blood sample)
* Hypotension (systolic BP \< 90 mmHg)
* Mottling beyond edge of kneecap (i.e., Mottling score \>2)53
* Severe oliguria, i.e., diuresis \< 0.1 ml/kg/h, during the first 4 hours of admission
All patients will be ensured min. 1 L of oral/intravenous fluids in 24 hours and electrolytes can be corrected.
CONTROL INTERVENTION:
In the usual care group there will be no upper limit for the use of IV fluids.
OUTCOMES:
The primary outcome is 24-hour intravenous crystalloid fluid administration. Key secondary outcomes are: Feasibility measures: Number of patients with major protocol violations, Number of patients screened vs included, Time from admission to inclusion, Number of patients lost to follow up in terms of 24-hour fluids, Accumulated serious adverse reactions and events (SAEs + Suspected Unexpected Serious Adverse Reaction (SUSARs)) within 48 hours in-hospital, Total fluids (oral and intravenous) at 24 hours,
TRIAL-SIZE:
124 patients will be randomized to restrictive fluid administration or usual care within 24 hours of randomization
Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.
OBJECTIVES:
The aim of the REFACED Sepsis trial is 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.
DESIGN:
REFACED Sepsis is a multicenter, randomized, parallel-group, open-labeled, feasibility trial
POPULATION:
ED patients with sepsis expected to be admitted for ≥ 24 hours
EXPERIMENTAL INTERVENTION:
In the IV fluid restriction group no IV fluids should be given unless one of the below mentioned occurs;
A fluid bolus of 250 ml isotonic crystalloid may be given within 15 minutes if one of the following occurs (hypoperfusion criteria):
* Lactate concentration ≥ 4 mmol/l (arterial or venous blood gas/blood sample)
* Hypotension (systolic BP \< 90 mmHg)
* Mottling beyond edge of kneecap (i.e., Mottling score \>2)53
* Severe oliguria, i.e., diuresis \< 0.1 ml/kg/h, during the first 4 hours of admission
All patients will be ensured min. 1 L of oral/intravenous fluids in 24 hours and electrolytes can be corrected.
CONTROL INTERVENTION:
In the usual care group there will be no upper limit for the use of IV fluids.
OUTCOMES:
The primary outcome is 24-hour intravenous crystalloid fluid administration. Key secondary outcomes are: Feasibility measures: Number of patients with major protocol violations, Number of patients screened vs included, Time from admission to inclusion, Number of patients lost to follow up in terms of 24-hour fluids, Accumulated serious adverse reactions and events (SAEs + Suspected Unexpected Serious Adverse Reaction (SUSARs)) within 48 hours in-hospital, Total fluids (oral and intravenous) at 24 hours,
TRIAL-SIZE:
124 patients will be randomized to restrictive fluid administration or usual care within 24 hours of randomization
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: