Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
ConditionSeptic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Confirmed or suspected pregnancy
Previous inclusion in the trial
Screened more than 12 hours after ICU admission
Trial design
Design model
Parallel
Treatments tested in this trial
Protocolised reduction of non-resuscitation fluids
Other interventionMaintenance 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)
Usual care
Other interventionParticipants 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
Treatment groups
1,850 Participants
are divided into 2 treatment groupsGroup A: Protocolised reduction of non-resuscitation fluidsExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
All-cause mortality
Time frame
90 days after inclusionSecondary outcomes
1
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 days2
Mechanical ventilation-free days
Mechanical ventilation-free days
Time frame
Within 90 days after inclusion3
Cognitive function
Cognitive function measured using the Montreal Cognitive Assessment (MoCA)
Time frame
6 months after inclusion4
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 inclusionOther outcomes
1
Hospital-free days
Hospital-free days
Time frame
Within 90 days after inclusion2
Vasopressor-free days
Vasopressor-free days
Time frame
Within 90 days after inclusion3
Renal replacement therapy (RRT)-free days
RRT-free days
Time frame
Within 90 days after inclusion4
Major adverse kidney events (MAKE)
The composite of death, new receipt of renal replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value)
Time frame
90 days after inclusionSponsors and contacts
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Source ClinicalTrials.gov