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Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Clermont-Ferrand
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In plain words

What the trial is, and whether it could suit you

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 increased capillary permeability and vasodilation, resulting in hypotension and tissue hypoxia. Early identification and treatment of tissue hypoperfusion are pivotal components of initial resuscitation to limit progression to multiple organ dysfunction and death. The 2021 Surviving Sepsis Guidelines recommend guiding initial resuscitation by targeting decreases in serum lactate levels in patients with elevated lactate. However, although elevated lactate levels may reflect tissue hypoxia, serum lactate is not a direct marker of tissue perfusion. Hyperlactatemia may be attributable to mechanisms other than tissue hypoperfusion, such as accelerated aerobic glycolysis driven by excessive β-adren

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • CO2gap-guided resuscitation strategy
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Where

28 sites
CHu Angers
Angers, France
CH Aurillac
Aurillac, France
CH de la Côte Basque
Bayonne, France
CHU Bordeaux Hôpital Haut Lévèque
Bordeaux, France
CHU Bordeaux Pellegrin Hospital
Bordeaux, France
CHU Clermont-Ferrand Estaing
Clermont-Ferrand, France
CHU Clermont-Ferrand Gabriel Montpied
Clermont-Ferrand, France
CHU Dijon
Dijon, France

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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