SepsisHEMOCAPNCT06910891
Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
A study testing measurement of the peripheral perfusion index and marbling assessment in people with Sepsis and Emergency Care, run by University Hospital, Limoges at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Emergency Care, Microcirculation
- What is being tested?
- measurement of the peripheral perfusion index and marbling assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 6 sitesFrance
- Study dates
- 20 Sep 2025to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Brive Hospital
Brivé, 19100
Pierrick BARDOU
- Recruiting
Guéret Hospital
Guéret, 23000
Amaury GALAUD
- Recruiting
Limoges University Hospital
Limoges, 87000
Manon DUMOLARD
- Recruiting
Saint Junien Hospital
Saint-Junien, 87200
Morgan GAURIAT
- Recruiting
Tulle Hospital
Tulle, 19012
Philippe DUPUY
- Recruiting
Ussel Hospital
Ussel, 19200
Cyril MOESCH
About this study
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.
Read the 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
- Being tested
- measurement of the peripheral perfusion index and marbling assessment
- Keywords
- microcirculation, septic patient, organ dysfunction, sepsis, peripheral perfusion index, emergency unit
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of the peripheral perfusion index and marbling assessmentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Diagnostic Test: measurement of the peripheral perfusion index and marbling assessment |
| Control arm | No intervention | Patients will benefit from treatment according to current standards of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of patients presenting clinical deterioration during emergency care
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
Measured: between time of inclusion and 24 hours after
Secondary outcomes (6)
Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department
Measured: from admission to the Emergency Department to 3 hours after
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)
Measured: between Hours 0 and Hours 24
Number and proportion of deaths on Day 7
Measured: 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
Measured: 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
Measured: hour 0
Number and proportion of patients sent home, conventional hospitalization or intensive care
Measured: from enrollment to the end of the subject participation at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start20 Sep 2025
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental interventional study of the here-elsewhere type, open and multicenter
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910891
- Sponsor's protocol ID
- 87RI24_0047 (HEMOCAP
- Other IDs
- 2025-A00216-43
- Acronym
- HEMOCAP
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
- ClinicalTrials.gov ID
- NCT06910891
- Acronym / sponsor ID
- HEMOCAP / 87RI24_0047 (HEMOCAP
- Conditions
- Sepsis, Emergency Care, Microcirculation
- Keywords
- microcirculation, septic patient, organ dysfunction, sepsis, peripheral perfusion index, emergency unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental interventional study of the here-elsewhere type, open and multicenter
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Diagnostic Test: measurement of the peripheral perfusion index and marbling assessmentAs 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. |
| Control arm | No intervention | –Patients will benefit from treatment according to current standards of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of the peripheral perfusion index and marbling assessmentin 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 | Diagnostic test | Intervention arm |
Primary outcome
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
6 secondary outcomes
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
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)
Time frame: 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
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
The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of the peripheral perfusion index and marbling assessment in people with Sepsis and Emergency Care, run by University Hospital, Limoges at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaelle NARDOT-SUCHAUD (0519761835, Anaelle.NARDOT-SUCHAUD@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of patients presenting clinical deterioration during emergency care (time frame: between time of inclusion and 24 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.