Phase 4
Completed N=1,554
The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
Source: ClinicalTrials.gov NCT03668236 ↗Enrolled (actual)
1,554
Serious AEs
30.0%
Results posted
Feb 2025
Primary outcomePrimary: 90-day Mortality — 323; 329 Participants
◆ Published Evidence
Highly cited
110citations · ~18 / year
Lower vs Higher Fluid Volumes During Initial Management of Sepsis: A Systematic Review With Meta-Analysis and Trial Sequential Analysis.
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.
Linked Publications (5)
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Lower vs Higher Fluid Volumes During Initial Management of Sepsis: A Systematic Review With Meta-Analysis and Trial Sequential Analysis.
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Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock.
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Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial.
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Effects of IV Fluid Restriction According to Standard Fluid Treatment Intensity Across Conservative Versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) Trial Sites.
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Effects of IV fluid restriction according to site-specific intensity of standard fluid treatment-protocol.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.