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Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06910891
Acronym
HEMOCAP
Enrollment
556
Registered
2025-04-04
Start date
2025-09-20
Completion date
2027-03-28
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Care, Microcirculation, Sepsis

Keywords

microcirculation, septic patient, organ dysfunction, sepsis, peripheral perfusion index, emergency unit

Brief 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.

Interventions

DIAGNOSTIC_TESTmeasurement 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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Quasi-experimental interventional study of the here-elsewhere type, open and multicenter

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number and proportion of patients presenting clinical deterioration during emergency carebetween time of inclusion and 24 hours afterClinical 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

Secondary

MeasureTime frame
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)between Hours 0 and Hours 24
Number and proportion of deaths on Day 7from enrollement to the end of the patient participation at Day 7
Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Departmentfrom admission to the Emergency Department to 3 hours after
The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physicianhour 0
Number and proportion of patients sent home, conventional hospitalization or intensive carefrom enrollment to the end of the subject participation at day 7
Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency carefrom enrollment to the end of the subject participation at day 7

Countries

France

Contacts

Primary ContactAnaelle NARDOT-SUCHAUD
Anaelle.NARDOT-SUCHAUD@chu-limoges.fr0519761835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026