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New treatment option for Sepsis - to Reduce Mortality in the Intensive Care Unit
Official title Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
ClinicalTrials.gov ID: NCT07179276
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Aurillac, France
- Bayonne, France
- Bordeaux, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Le Puy-en-Velay, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Moulins, France
- Nantes, France
- Nîmes, France
- Paris, France
- Poitiers, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
- Vichy, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Aurillac, France; Bayonne, France; Bordeaux, France; Clermont-Ferrand, France; Dijon, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.