Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients (HEMOCAP)

November 18, 2025 updated by: University Hospital, Limoges
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

556

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brivé, France, 19100
        • Recruiting
        • Brive Hospital
        • Principal Investigator:
          • Pierrick BARDOU
      • Guéret, France, 23000
        • Recruiting
        • Guéret Hospital
        • Principal Investigator:
          • Amaury GALAUD
      • Limoges, France, 87000
        • Recruiting
        • Limoges University Hospital
        • Principal Investigator:
          • Manon DUMOLARD
      • Saint-Junien, France, 87200
        • Recruiting
        • Saint Junien Hospital
        • Principal Investigator:
          • Morgan GAURIAT
      • Tulle, France, 19012
        • Recruiting
        • Tulle Hospital
        • Principal Investigator:
          • Philippe DUPUY
      • Ussel, France, 19200
        • Recruiting
        • Ussel Hospital
        • Principal Investigator:
          • Cyril MOESCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
As soon as an eligible patient is identified by the nurse, 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. This measurement will be validated by the senior doctor of the Sepsis Department. When the peripheral perfusion index will be ≥ 3 sec and/or the marbling score ≥ 1, a first vascular filling test of 500 cc over 30 minutes will be started, regardless of the value of the hemodynamic parameters.
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
No Intervention: Control arm
Patients will benefit from treatment according to current standards of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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):

  1. Arterial hypotension defined by systolic blood pressure (SBP) ≤ 100 mmHg

  2. Implementation of treatment for organ support:

    • Vasopressor or inotrope
    • Invasive ventilation
  3. Abnormal lactate concentration (> 2mmol/L), without improvement (absence of decay)
  4. Patient admitted in intensive care unit
  5. Death
between time of inclusion and 24 hours after

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from admission to the Emergency Department to 3 hours after
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)
Time Frame: between Hours 0 and Hours 24
between Hours 0 and Hours 24
Number and proportion of deaths on Day 7
Time Frame: from enrollement to the end of the patient participation at Day 7
from enrollement to the end of the patient participation at Day 7
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
from enrollment to the end of the subject participation at day 7
The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician
Time Frame: hour 0
hour 0
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
from enrollment to the end of the subject participation at day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2025

Primary Completion (Estimated)

March 28, 2027

Study Completion (Estimated)

March 28, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI24_0047 (HEMOCAP
  • 2025-A00216-43 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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