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How to quickly determine the severity of an infectious disease from a complete blood count?

Evaluation of monocyte distribution width for early detection of sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13887392
Enrollment
1500
Registered
2023-11-07
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Evaluation of monocyte distribution width for early detection of sepsis Haematological Disorders

Interventions

This is a non-interventional cohort study. Monocyte distribution width (MDW) results will be unavailable to the physicians in charge and subjects will not be managed based on the results of MDW. All r

Sponsors

Beckman Coulter
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All consecutive adults presenting to the Emergency department and subsequently admitted to the hospital (medical ward or intensive care unit) and for whom complete blood count with differential is ordered upon presentation will be included into the study. Patients will be categorized into several pre-defined groups: 1. Patients with and without infections regardless the presence of SIRS criteria; 2. Patients with definitive diagnosis of infection or sepsis (defined according to Sepsis-3 criteria) will further be subdivided in clinically documented infection/sepsis and microbiologically documented infection/sepsis; 3. Microbiologically documented infection/sepsis will further be subdivided into bacterial and non-bacterial infections depending on the type of germ cultured or identified otherwise (PCR etc.); 4. Patients with infection will be compared to patients fulfilling criteria for sepsis or septic shock; 5. Patients will also be categorized into infected-SIRS and non-infected SIRS groups and analyzed separately.

Exclusion criteria

Exclusion criteria: 1. Previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study) 2. Subjects discharged from the ED 3. Subjects with CRP and PCT not performed 4. Pregnant women 5. Relevant limitations of therapy

Design outcomes

Primary

MeasureTime frame
The following primary outcome measures are assessed using medical records and blood collected at the time of the emergency department visit: 1. Diagnostic performance of monocyte distribution width (MDW) in adult patients with community-acquired uncomplicated infections, sepsis and septic shock measured using a UniCelDxH 900 analyzer (Beckman Coulter, Inc., Brea, CA) using blood collected at the time of the emergency department visit 2. C-reactive protein measured using standard methods in all patients 3. Procalcitonin measured using standard methods when clinically indicated

Secondary

MeasureTime frame
The following secondary outcome measures are measured using medical records and blood collected at the time of the emergency department visit: 1. Sources of heterogeneity in the estimates of diagnostic accuracy (e.g. immunosuppression, cancer, autoimmunity, chronic comorbidities, etc.) 2. The influence of different types of pathogens (e.g. gram-positive, gram-negative, fungal, viral) and sites of infection on MDW 3. Diagnostic accuracy of MDW in the distinction of sepsis from non-infectious conditions

Countries

Czech Republic

Contacts

Public ContactPetr Lehnert
lehnert.petr@seznam.cz+420 731665417

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026