Using bedside microcirculation checks to guide early fluids in sepsis
Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
This study will test whether nurses measuring peripheral perfusion and skin mottling in adults with suspected sepsis in the emergency department and prompting an early 500 mL fluid bolus when perfusion looks poor can reduce short-term worsening.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 556 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 6 sites (Brivé and 5 other locations) |
| Trial ID | NCT06910891 on ClinicalTrials.gov |
What this trial studies
Adults who present to participating emergency departments within six hours of suspected sepsis will have nurse-measured peripheral perfusion index and a skin mottling (marbling) check at the bedside. If the bedside perfusion measures indicate poor microcirculation, a supervised 500 mL vascular filling (fluid bolus) over 30 minutes is given after medical confirmation. Patients are followed for seven days to record clinical course and outcomes, including deterioration and mortality. The intervention tests whether adding routine microcirculation checks to usual care leads to earlier fluid resuscitation and improved short-term prognosis.
Who should consider this trial
Good fit: Adults (age ≥18) presenting to the participating emergency departments with suspected sepsis within six hours, able to consent and covered by social security, are the intended participants.
Not a fit: Patients who are already hypotensive on arrival, have already received the specified 500 mL filling test, are moribund, pregnant or breastfeeding, under legal guardianship, or otherwise excluded are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could detect occult tissue hypoperfusion earlier and prompt timely fluids to reduce organ dysfunction and short-term deterioration in sepsis.
How similar studies have performed: Observational studies and meta-analyses show that microcirculatory abnormalities predict deterioration and death in severe infections, but no interventional trials have yet proven that nurse-driven microcirculation-guided early fluids improve outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Admitted to the Emergency Department for suspected Sepsis for less than 6 hours according to international Sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°C with a suspected infectious source + Score NEWS 2 greater than or equal to 2) 3. Affiliated to a social security system 4. Having agreed to participate in this study Exclusion Criteria: 1. Patient with arterial hypotension (SBP ≤ 100 mmHg) on admission 2. Patient having already received a 500mL filling test over 30 minutes 3. Patients moribund according to the investigator 4. Pregnancy or breastfeeding 5. Patient under guardianship, curatorship or safeguard of justice
Where this trial is running
Brivé and 5 other locations
- Brive Hospital — Brivé, France (Recruiting)
- Guéret Hospital — Guéret, France (Recruiting)
- Limoges University Hospital — Limoges, France (Recruiting)
- Saint Junien Hospital — Saint-Junien, France (Recruiting)
- Tulle Hospital — Tulle, France (Recruiting)
- Ussel Hospital — Ussel, France (Recruiting)
Study contacts
- Study coordinator: Anaelle NARDOT-SUCHAUD
- Email: Anaelle.NARDOT-SUCHAUD@chu-limoges.fr
- Phone: 0519761835
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.