Septic shock MedDRA version: 20.0 Level: LLT Classification code 10040050 Term: Sepsis NOS System Organ Class: 100000004862
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sodium Chloride
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Pharmaceutical Fo
Sponsors
Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following criteria must be fulfilled: - Aged 18 years or above - Admitted to the ICU or plan to be admitted to the ICU regardless of trial participation - Septic shock defined according to the Sepsis-3 criteria: o Suspected or confirmed site of infection or positive blood culture AND o Ongoing infusion of vasopressor/inotrope agent to maintain a mean arterial blood pressure of 65 mmHg or above AND o Lactate of 2 mmol/L or above in any plasma sample performed within the last 3-hours - Have received at least 1 L of IV fluid (crystalloids, colloids or blood products) in the last 24-hours prior to screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 754 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: We will exclude patients who fulfil any of the following criteria: - Septic shock for more than 12 hours at the time of screening because we want to include patients early in their course - Life-threatening bleeding as these patients need specific fluid/blood product strategies - Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy - Known pregnancy. - Consent not obtainable as per the model approved for the specific site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the CLASSIC trial is to assess benefits and harms of IV fluid restriction vs. standard of care on patient-important outcome measures in adult ICU patients with septic shock.;Secondary Objective: Not applicable;Primary end point(s): All-cause mortality at day 90 after randomisation;Timepoint(s) of evaluation of this end point: day 90 after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: during ICU admission, day 90 after randomisation or 1 year after randomisation; Secondary end point(s): - Number of participants with one or more serious adverse events (SAEs) in the ICU defined as ischaemic events (cerebral, cardiac, intestinal or limb ischaemia) or as a new episode of severe acute kidney injury (modified KDIGO3) - Number of participants with one or more serious adverse reactions (SARs) to IV crystalloids in the ICU. - Days alive at day 90 without life support (vasopressor / inotropic support, invasive mechanical ventilation or renal replacement therapy) - Days alive and out of hospital at day 90 - All-cause mortality at 1-year after randomisation - HRQoL 1-year after randomisation measured using the EuroQoL (EQ)-5D-5L and EQ-VAS scores. Participants who have died will be assigned the lowest possible scores - Cognitive function 1-year after randomisation as assessed by the Montreal Cognitive Assessment (MoCa) score | — |
Countries
Canada, Denmark, Finland, Spain, Sweden
Contacts
Public ContactClinical Trials Information
Dept. of Intensive Care Rigshospitalet
Outcome results
None listed