How to quickly determine the severity of an infectious disease from a complete blood count?
| ISRCTN | ISRCTN13887392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13887392 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 393/2020 |
| Sponsor | Beckman Coulter |
| Funder | Lékařská Fakulta v Plzni, Univerzita Karlova |
- Submission date
- 04/10/2023
- Registration date
- 07/11/2023
- Last edited
- 18/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Sepsis is a serious problem in hospitals, and it's the main reason why some patients don't make it. It affects a lot of people and makes them sicker, leading to more deaths and expensive medical bills. The ways doctors currently use to find out if someone has sepsis are not perfect. So, new methods are required that can tell us if someone might get sepsis earlier. This is important because when it is known earlier, treatment can be started sooner to give the patient a better chance of getting better. A recent study in emergency rooms found that looking at a certain type of blood cell, called a monocyte, can help. If there's a big change in the number of these cells in your blood, it might mean you have sepsis. They found that if the number goes up by more than 20.0 units, it is a good sign that someone might have sepsis or be at risk of getting it. Right now, this test called the monocyte distribution width (MDW) can be done as part of a regular blood test, and it's not too expensive or slow. So, it could be a really useful tool to spot sepsis early and start treatment as soon as possible.
Who can participate?
All adults who go to the emergency department and are later admitted to the hospital (either to the regular medical ward or the intensive care unit), and whose doctors order a complete blood count with differential when they first arrive, will be part of this study.
What does the study involve?
This is a non-interventional cohort study. MDW results will be unavailable to the physicians in charge and subjects were not managed based on the results of MDW. All routine clinical and paraclinical data will be recorded in and extracted from a hospital's electronic medical records.
What are the possible benefits and risks of participating?
None. The study does not require any additional blood draws or procedures that would not already have been performed as part of their standard medical care.
Where is the study run from?
Beckman Coulter (Czech Republic)
When is the study starting and how long is it expected to run for?
August 2020 to December 2022
Who is funding the study?
Faculty of Medicine in Pilsen (Czech Republic)
Who is the main contact?
Prof. MUDr. Martin Matějovič, Ph.D., matejovic@fnplzen.cz
Contact information
Scientific, Principal investigator
alej Svobody 80
Pilsen
32300
Czech Republic
 ORCID ID |
0000-0001-9814-5256 |
|---|---|
| Phone | +420 604753841 |
| matejovic@fnplzen.cz |
Public
Ječná 1991
Beroun
26601
Czech Republic
| Phone | +420 731665417 |
|---|---|
| lehnert.petr@seznam.cz |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational exploratory prospective non-interventional cohort study in single-center high-volume academic center |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Evaluation of monocyte distribution width for early detection of sepsis |
| Study objectives | Monocyte distribution width (MDW) provides superior/additional diagnostic value for early detection of life-threatening infections and sepsis as compared to already available from established clinical assessments and laboratory investigations. |
| Ethics approval(s) |
Approved 06/08/2020, Ethic committee University Hospital and Faculty of Medicine, Charles University Pilsen (Edvarda Beneše 13, Pilsen, 30599, Czech Republic; +420 377402239; suchyd@fnplzen.cz), ref: 343/2020 |
| Health condition(s) or problem(s) studied | Evaluation of monocyte distribution width for early detection of sepsis |
| Intervention | 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 routine clinical and paraclinical data will be recorded and extracted from a hospital's electronic medical records. The total duration of observation is from the time of hospital admission to the time of hospital discharge. |
| Intervention type | Other |
| Primary outcome measure(s) |
The following primary outcome measures are assessed using medical records and blood collected at the time of the emergency department visit: |
| Key secondary outcome measure(s) |
The following secondary outcome measures are measured using medical records and blood collected at the time of the emergency department visit: |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 1500 |
| Total final enrolment | 1925 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 31/10/2020 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Pilsen
30100
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author upon reasonable request, Prof. MUDr. Martin Matějovič, Ph.D., matejovic@fnplzen.cz. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/07/2024 | 18/10/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2024: Publication reference added.
24/10/2023: Ethic Committee University Hospital and Faculty of Medicine, Charles University Pilsen, Czechia.
