Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05076435 |
Other study ID # |
RECEM0001 |
Secondary ID |
2021-000224-351- |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
November 3, 2021 |
Est. completion date |
March 19, 2022 |
Study information
Verified date |
March 2022 |
Source |
University of Aarhus |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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