Septic Shock
Conditions
Keywords
septic shock
Brief 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.
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)
OTHERUsual care
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
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The clinical team caring for participants will not be blinded due to the nature of the intervention. The participants and their family will not be actively informed about group allocation. The steering group, author group, trial statistician, outcome assessors, prognosticators, the trial coordinating team, manuscript writers and the data safety and monitoring committee will be blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Confirmed or suspected pregnancy * Previous inclusion in the trial * Screened more than 12 hours after ICU admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 90 days after inclusion | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications in the ICU | From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | 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. |
| Mechanical ventilation-free days | Within 90 days after inclusion | Mechanical ventilation-free days |
| Cognitive function | 6 months after inclusion | Cognitive function measured using the Montreal Cognitive Assessment (MoCA) |
| Health-Related Quality of Life | 6 months after inclusion | Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS) |
Countries
Finland, Sweden, United Kingdom
Contacts
CONTACTPeter Bentzer
CONTACTJane Fisher
PRINCIPAL_INVESTIGATORPeter Bentzer
Region Skåne
Outcome results
None listed