The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
98
* Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated * Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances * Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice * Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this * Parenteral nutrition is administered according to local protocol * Intravenous medications are concentrated according to a predefined protocol * Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that 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) are given at a dose of 1 ml/kg/h unless local protocol states otherwise * Glucose is used at maximal concentration of 10% unless local protocol states otherwise. * Medications are concentrated according to local protocol
Sahlgrenska University Hospital
Gothenburg, Sweden
Halmstad Hospital
Halmstad, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Kristianstad Hospital
Kristianstad, Sweden
Difference in fluid administration
Total difference in litres of administered fluids between groups
Time frame: Within the first three days after inclusion (days 0-3)
Proportion of participants with sufficient clinical outcome data
Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia)
Time frame: Within 90 days after inclusion
Proportion of participants assessed by EQ5D-5L and MoCA
Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA)
Time frame: 6 months after inclusion
Inclusion of eligible patients
Fraction of all eligible patients who were randomised and consented
Time frame: During inclusion
Protocol violations
Fraction of patients experiencing at least one protocol violation
Time frame: Within 90 days after inclusion
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Skåne University Hospital, Lund
Lund, Sweden
Skåne University Hospital, Malmö
Malmö, Sweden
Östersund Hospital
Östersund, Sweden
Uppsala University Hospital
Uppsala, Sweden