Veno-arterial CO2 gap-guided early resuscitation for septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CARBON trial compares a veno-arterial carbon dioxide partial pressure difference (CO2gap)-guided resuscitation strategy with a lactate level-guided strategy in adults with septic shock. Participants are adults admitted to participating ICUs who meet Sepsis-3 criteria, have lactate >2 mmol/L, require vasopressors, and are enrolled early in shock. Patients are managed according to the assigned algorithm with serial CO2gap or lactate measurements used to guide fluids, vasopressors, and other hemodynamic therapy, and mortality is the primary outcome. The trial is conducted at university and regional hospitals in France to determine if CO2gap-guided care reduces deaths compared with standard lactate-guided resuscitation.

Why it matters

Who can join: the full rules

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

Where it's running

• CH de la Côte Basque
  Bayonne, France Recruiting
• CHU Bordeaux Hôpital Haut Lévèque
  Bordeaux, France Recruiting
• CHU Bordeaux Pellegrin Hospital
  Bordeaux, France Recruiting
• CHU Clermont-Ferrand Estaing
  Clermont-Ferrand, France Recruiting
• CHU Clermont-Ferrand Gabriel Montpied
  Clermont-Ferrand, France Recruiting
• CHU Dijon
  Dijon, France Recruiting

Study contacts

• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: 0473754963

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive hemodynamic guidance for sepsis care on medical wards

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• Personalized Fluid Resuscitation in the Emergency Department

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.