Understanding immune response in septic shock patients
Official title: Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration
Run by Hospices Civils de Lyon · NCT04067674 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 305 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | October 21, 2019 |
| Main results expected | November 21, 2026 |
| Study ends | November 21, 2026 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT04067674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the immune response in septic shock has been studied, this specific observational approach focusing on the transition to immunosuppression is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone
In septic shock, this trial tests whether adding fludrocortisone (50 mcg or 100 mcg daily) to hydrocortisone improves survival and recovery compared with placebo.
-
Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Personalized Fluid Resuscitation in the Emergency Department
This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.
-
Discordance between capillary refill time and oxygen use in septic shock
This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
-
Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock
This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.