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NCT Number: NCT06910891

Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

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.

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Key information

Conditions

Sepsis Disease Attributes Emergencies Emergency Care Infections Inflammation Microcirculation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brive Hospital, Brivé, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • 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)
  • Affiliated to a social security system
  • Having agreed to participate in this study

Exclusion criteria

  • Patient with arterial hypotension (SBP ≤ 100 mmHg) on admission
  • Patient having already received a 500mL filling test over 30 minutes
  • Patients moribund according to the investigator
  • Pregnancy or breastfeeding
  • Patient under guardianship, curatorship or safeguard of justice

Treatment and study plan

measurement of the peripheral perfusion index and marbling assessment

Diagnostic Test

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

Primary outcomes

  1. Number and proportion of patients presenting clinical deterioration during emergency care

    Time frame: between time of inclusion and 24 hours after

    Clinical deterioration is defined by (composite criterion):

    • Arterial hypotension defined by systolic blood pressure (SBP) ≤ 100 mmHg
    • Implementation of treatment for organ support:
    • Vasopressor or inotrope
    • Invasive ventilation
    • Abnormal lactate concentration (> 2mmol/L), without improvement (absence of decay)
    • Patient admitted in intensive care unit
    • Death

Secondary outcomes

  1. Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department

    Time frame: from admission to the Emergency Department to 3 hours after

  2. Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)

    Time frame: between Hours 0 and Hours 24

  3. Number and proportion of deaths on Day 7

    Time frame: from enrollement to the end of the patient participation at Day 7

  4. Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care

    Time frame: from enrollment to the end of the subject participation at day 7

  5. The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician

    Time frame: hour 0

  6. Number and proportion of patients sent home, conventional hospitalization or intensive care

    Time frame: from enrollment to the end of the subject participation at day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Anaelle NARDOT-SUCHAUD

CONTACT

[email protected]

0519761835

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: HEMOCAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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