Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)

No IV fluids unless one of the extenuating circumstances occur;

1. In case of severe hypoperfusion or severe circulatory impairment defined by either: 1) Lactate≥4 mmol/L, 2) Hypotension (systolic BP < 90 mmHg), 3) Mottling beyond the kneecap (mottling score >2) OR 4) Urinary output<0.1 mL/kg bodyweight/h (only in the first 4hrs after randomization) then a bolus of 250 ml of IV crystalloid solution may be given followed by re-evaluation
2. In case of overt fluid losses (e.g. vomiting, large aspirates,) IV fluid may be given to correct for the loss, but not above the volume lost.

3. In case the oral/enteral route for water or electrolyte solutions is contraindicated or has failed, IV fluids may be given to:

   Correct dehydration or electrolyte deficiencies Ensure a total fluid input of 1 L in 24hrs

4. IV fluids may be given as carrier for medication, but with lowest possible volume

Types of fluids in both intervention groups:

• Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
• Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
• Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.

There will be no upper limit for the use of either IV or oral/enteral fluids

1. IV fluids should be given in the case of hypoperfusion or circulatory impairment and should be continued as long as hemodynamic variables improve including static or dynamic variable(s) as chosen by the clinicians. These criteria are based on the Surviving Sepsis Campaign guideline.
2. IV fluids should be given as maintenance if the ICU has a protocol recommending maintenance fluid
3. IV fluids should be given to substitute expected or observed loss, dehydration or electrolyte derangements

Types of fluids in both intervention groups:

• Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
• Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
• Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy.