Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Region Skane
1,850 participants
Nov 27, 2023
INTERVENTIONAL
Conditions
Summary
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.
Eligibility
Inclusion Criteria2
- Adult (≥ 18 years of age)
- Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation \[\> 1L within 12 h of screening\]) and need for vasopressors at the time of screening.
Exclusion Criteria3
- Confirmed or suspected pregnancy
- Previous inclusion in the trial
- Screened more than 12 hours after ICU admission
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Interventions
Maintenance fluid: discontinued if cumulative fluid balance is positive and patient is not dehydrated Intravenous fluid and enteral water: as needed to correct electrolyte disturbances Enteral nutrition (at least 2 kcal/ml): per local practice Glucose (conc. ≥20%, dose ≤1g/kg/day): may be used as nutrition if enteral feeding not tolerated starting 72h after inclusion. May be started earlier in patients with insulin-dependent diabetes or risk of hypoglycemia per local practice Parenteral nutrition: per local practice Intravenous medications: concentrated according to a predefined protocol Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids so the total dose of fluids covers the daily need of water (about 1ml/kg/h)
Participants receive non-resuscitation fluids according to local routines, with the following stipulations: Maintenance fluids (crystalloids and/or glucose and/or enteral water): given at a dose of 1 ml/kg/h unless local protocol states otherwise Glucose: used at maximal concentration of 10% unless local protocol states otherwise. Medications: concentrated per local protocol
Locations(22)
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NCT06140147