Understanding immune response in septic shock patients
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration
This study looks at how the immune system changes over time in patients with septic shock to see if it can help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 305 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04067674 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with septic shock, a critical condition that significantly impacts immune function. It aims to analyze the immune response over time, particularly the transition from a pro-inflammatory phase to a state of prolonged immunosuppression. Blood samples will be collected from patients in the ICU to assess immune alterations and the potential reactivation of dormant viruses. The findings could provide insights into the immune dynamics in septic patients and inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been admitted to the ICU with a diagnosis of septic shock within 48 hours.
Not a fit: Patients who are pregnant, breastfeeding, or involved in other interventional studies that may affect biological results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for septic shock patients, potentially enhancing their recovery and reducing mortality rates.
How similar studies have performed: While the immune response in septic shock has been studied, this specific observational approach focusing on the transition to immunosuppression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Patient admitted to ICU * Diagnosis of septic shock within less than 48h at time of screening defined by : * Presence of a microbiologically diagnosed or suspected infection * Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission * Presence of an hyperlactatemia \> 2 mmol/L (18 mg/dL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml/kg) * Blood sample at D3/D4 available (lab working days) * Non opposition to study participation obtained from patient or next of kin Exclusion Criteria: * Pregnant or breastfeeding woman * Patient with no social security insurance, with restricted liberty or under legal protection * Language barrier * Patient taking part in interventional study about medicin that could interfere with biologic results
Where this trial is running
Lyon
- Hôpital Edouard Herriot — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Fabienne VENET, PhD — Hospices Civils de Lyon
- Study coordinator: Fabienne VENET, PhD
- Email: fabienne.venet@chu-lyon.fr
- Phone: 04 72 11 97 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.