The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Perner
• Collaborators: Centre for Research in Intensive Care (CRIC); Rigshospitalet, Denmark; Scandinavian Critical Care Trials Group

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:

• Suspected or confirmed site of infection or positive blood culture AND

• Ongoing infusion of vasopressor/inotrope agent to maintain a mean arterial blood pressure of 65 mmHg or above AND

• 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.

Exclusion Criteria:

Patients who fulfil any of the following criteria will be excluded:

• Septic shock for more than 12 hours at the time of screening as these patients are no longer 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