Phase 4
N=1,554
The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03668236 ↗Enrolled (actual)
1,554
Serious AEs
30.0%
Results posted
Feb 2025
Primary outcome: Primary: 90-day Mortality — 323; 329 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isotonic crystalloids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anders Perner, MD, PhD
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 90-day Mortality |
323; 329 | — |
| SECONDARY Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU |
221; 238 | — |
| SECONDARY Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU. |
31; 32 | — |
| SECONDARY Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy) |
77; 77 | — |
| SECONDARY Days Alive and Out of Hospital at Day 90 |
21; 33 | — |
| SECONDARY All-cause Mortality at 1-year After Randomisation |
385; 383 | — |
| SECONDARY Health-related Quality of Life 1 Year After Randomisation |
0; 0 | — |
| SECONDARY Cognitive Function 1-year After Randomisation |
0; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03668236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.