Status:
NOT_YET_RECRUITING
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Sepsis - to Reduce Mortality in the Intensive Care Unit
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sepsis is a dysregulated host response to infection that leads to life-threatening organ dysfunction and represents a major healthcare problem. Septic shock is the most severe form, characterized by i...
Detailed Description
Main objective: The aim of the CARBON trial is to compare a veno-arterial CO2 difference-guided resuscitation strategy (CO2gap-guided strategy) with a lactate level-guided resuscitation on mortality i...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older AND
- Acutely admitted to a study ICU AND
- Primary diagnosis of septic shock according to the Sepsis-3 criteria and defined as:
- A suspected or documented site of infection or positive blood culture AND
- Acute increase of at least 2 points in the Sequential Organ Failure Assessment (SOFA) score consequent to the infection AND
- Having a serum lactate level \>2 mmol/l AND
- Requirement of vasopressors (any dose of norepinephrine) to maintain mean arterial pressure (MAP) ≥65 mmHg despite adequate fluid resuscitation (at least 1L of IV fluid in the last 24 hours prior to screening)
Exclusion
- Septic shock for more than 12 hours at the time of screening
- Primary cause of hypotension not due to sepsis (e.g., acute bleeding)
- Decision not to resuscitate (or to limit full care) or not to intubate taken before obtaining consent
- Death is deemed to be imminent or inevitable or patients with an underlying disease process with a life expectancy of less than 3 months
- Anticipated surgery during the first 24 hours after randomization
- Patient or their relatives' refusal to participate
- Patients participating in another RCT with interventions possibly compromising the primary outcome
- Prior enrollment in the CARBON trial
- Known to be pregnant.
- Legal protection (i.e., incompetence to provide consent and no guardian or incarceration)
- No affiliation with the French health care system
Key Trial Info
Start Date :
December 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07179276
Start Date
December 9 2025
End Date
December 31 2027
Last Update
September 30 2025
Active Locations (2)
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1
CHU Clermont-Ferrand Estaing
Clermont-Ferrand, France
2
CHU Clermont-Ferrand Gabriel Montpied
Clermont-Ferrand, France