The Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care Trial

Phase 1

Conditions: Septic shock
MedDRA version: 20.0Level: LLTClassification code 10040050Term: Sepsis NOSSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2018-000404-42-BE

Lead Sponsor: Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1554

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:
oSuspected or confirmed site of infection or positive blood culture AND
oOngoing infusion of vasopressor/inotrope agent to maintain a mean arterial blood pressure of 65 mmHg or above AND
oLactate 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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)<br>-Number of participants with one or more serious adverse reactions (SARs) to IV crystalloids in the ICU.<br>-Days alive at day 90 without life support (vasopressor / inotropic support, invasive mechanical ventilation or renal replacement therapy)<br>-Days alive and out of hospital at day 90<br>-All-cause mortality at 1-year after randomisation<br>-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<br>-Cognitive function 1-year after randomisation as assessed by the Montreal Cognitive Assessment (MoCa) score <br>;Timepoint(s) of evaluation of this end point: during ICU admission, day 90 after randomisation or 1 year after randomisation