NCT06910891

Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite early treatment, the deterioration and mortality of sepsis patients remains high. A possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. This interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.

Detailed description

Sepsis and its most serious form, septic shock, are a public health problem. Sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. Vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. Following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. In a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. Currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling. In this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. If peripheral perfusion index \> 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control. Patient will be followed up 7 days to determine outcome.

Conditions

• Sepsis
• Emergency Care
• Microcirculation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	measurement of the peripheral perfusion index and marbling assessment	in addition to the classic hemodynamic parameters measured in all patients, a measurement of the peripheral perfusion index (from 1 sec to 10 sec) and marbling assessment (scale from 0 to 5) will be performed

Timeline

• Start date: 2025-09-20
• Primary completion: 2027-03-28
• Completion: 2027-03-28
• First posted: 2025-04-04
• Last updated: 2025-11-21

Locations

6 sites across 1 country: France