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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,850
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
Helsinki University Hospital
Helsinki, Finland
RECRUITINGMortality
All-cause mortality
Time frame: 90 days after inclusion
Complications in the ICU
Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury.
Time frame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Mechanical ventilation-free days
Mechanical ventilation-free days
Time frame: Within 90 days after inclusion
Cognitive function
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
Time frame: 6 months after inclusion
Health-Related Quality of Life
Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)
Time frame: 6 months after inclusion
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RECRUITING...and 12 more locations