Exploring interstitial fluid in septic shock patients
Interstitial Fluid Composition in Patients with Septic Versus Non-septic Shock: an Exploratory Pilot Study
Centre Hospitalier Universitaire Dijon · NCT05039151
This study looks at the fluid in the body of patients with septic shock to see how it differs from those without sepsis, hoping to find better ways to manage their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05039151 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to investigate the composition of interstitial fluid in patients experiencing septic shock compared to those without sepsis. By analyzing interstitial fluid and blood samples, the study seeks to understand the fluid management challenges associated with septic shock, which is a critical condition often leading to intensive care unit admissions. The research focuses on the role of interstitial fluid in the body's response to severe infections and its implications for patient prognosis. The findings could provide insights into better management strategies for fluid resuscitation in septic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are under mechanical ventilation and sedation and have been diagnosed with septic shock within 24 hours of admission.
Not a fit: Patients who have conditions mimicking sepsis or those with disseminated intravascular coagulation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fluid management strategies for patients with septic shock, potentially enhancing their recovery and survival rates.
How similar studies have performed: While the specific approach of analyzing interstitial fluid in septic shock is exploratory, similar studies have indicated the importance of fluid management in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: COMMON INCLUSION CRITERIA * Patient under mechanical ventilation and sedation * Patient and/or trusted person (health care proxy) or close relative who has given their oral consent after being informed, * Age ≥ 18 years old, INCLUSION CRITERIA FOR THE SEPTIC SHOCK GROUP * Diagnosis within 24 hours of admission of septic shock as defined by : * A probable or confirmed infection * And a SOFA score ≥ 2 * And the need to introduce vasopressors to obtain a MAP ≥ 65 mmHg despite adequate vascular filling * And an arterial lactate \> 2 mmol/l * Norepinephrine dose greater than 0.1 μg/kg/min * Septic shock present for less than 48 hours INCLUSION CRITERIA FOR THE CONTROL GROUP - Absence of sepsis and shock from any cause within 2 months prior to inclusion Exclusion Criteria: * Disseminated intravascular coagulation (DIC) with haemorrhagic syndrome * Acute condition that can mimic sepsis : * Acute pancreatitis without signs of superinfection * Metformin Intoxication * Patient with an unfavourable prognosis within 24 hours * Patient under legal protection (safeguard of justice, guardianship or tutelage) * Pregnant or breastfeeding women * Patient not affiliated to national health insurance
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Jean-Pierre QUENOT
- Email: jean-pierre.quenot@chu-dijon.fr
- Phone: 03 80 29 36 85
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.
Conditions: Interstitial Liquid, Septic Shock