SepsisNCT04322942
Sepsis Prediction by Monocyte Distribution Width and Procalcitonin
An observational study of Sepsis and Diagnoses Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Diagnoses Disease
- What is being tested?
- Monocyte Distribution Width
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Apr 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Based on a target of 75% sensitivity and lower limit of 65%, a minimum of 63 (will target 100) septic patients would be required. Higher numbers may be enrolled in the study to ensure adequate representation of sepsis cases. Given the estimated prevalence of the disease in the emergency department population (5-10%%), the number of non-septic patients is predicted to be significantly higher than septic. Based on the estimated prevalence of subjects who present and have blood draw, a minimum of 100 non-septic cases will be collected.
Subject Inclusion Criteria
- Adult ≥20 years) subjects presenting to the ED with the chief complaints of fever, altered consciousness, hypotension, and dyspnea. CBC with differential testing performed, at presentation as part of their standard medical care.
- Subjects who have signed Informed Consent.
Subject Exclusion Criteria
- Previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
- Subjects discharged from the ED <72 hours
- Pregnant women
- Subjects not able to understand or sign Informed Consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou Medical Center
Taoyuan, 新北市, 333
Chih-huang Li, 0975360718, chhli2002@gmail.com
About this study
Official title: Comparison of the Diagnostic Accuracy of Monocyte Distribution Width and Procalcitonin on Sepsis in the Emergency Department
The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). In terms of exploring new diagnostic tools of sepsis, monocyte distribution width (MDW) was first reported in 2017. It was reported as part of the white blood cell (WBC) differential count. MDW greater than 20 and abnormal WBC count together were reported to provide a satisfactory accuracy. The area under curve (AUC) in predicting sepsis-2 is 0.852. It was proposed as a novel diagnostic tool of sepsis in the emergency setting. Nonetheless, the performance of MDW compared with the conventional biomarkers remained unknown. The aim of this study was to compare the diagnostic accuracy of MDW and PCT on sepsis in the emergency department.
- Conditions
- Sepsis, Diagnoses Disease
- Being tested
- Monocyte Distribution Width
- Keywords
- sepsis, procalcitonin, MDW
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocyte Distribution WidthDiagnostic test
Monocyte Distribution Width as part of the CBC result.
| Study group | Role | What they receive |
|---|---|---|
| Non-infection | Not described Receives: Diagnostic Test: Monocyte Distribution Width | |
| Infection without sepsis | Not described Receives: Diagnostic Test: Monocyte Distribution Width | |
| Sepsis-2 | Not described Receives: Diagnostic Test: Monocyte Distribution Width | |
| Sepsis-3 | Not described Receives: Diagnostic Test: Monocyte Distribution Width |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of predicting sepsis and sepsis-3 patients
MDW, PCT, and other laboratory tests were all obtained at the same time with 2 hours after the patient was admitted to the emergency department (ED). Sensitivity and specificity of different cutoff value were calculated. Best cutoff value will be decided by the perfomance.
Measured: within 2 hours after patient arrived ED.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start16 Apr 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-huang Li, MD, Principal investigator, Chang Gung Memorial Hospital, Linkou Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322942
- Sponsor's protocol ID
- XPRPG3J0051
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Li CH, Seak CJ, Chaou CH, Su TH, Gao SY, Chien CY, Ng CJ. Comparison of the diagnostic accuracy of monocyte distribution width and procalcitonin in sepsis cases in the emergency department: a prospective cohort study. BMC Infect Dis. 2022 Jan 4;22(1):26. doi: 10.1186/s12879-021-06999-4.
PubMed 34983430
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Accuracy of Monocyte Distribution Width and Procalcitonin on Sepsis in the Emergency Department
- ClinicalTrials.gov ID
- NCT04322942
- Acronym / sponsor ID
- XPRPG3J0051
- Conditions
- Sepsis, Diagnoses Disease
- Keywords
- sepsis, procalcitonin, MDW
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 26 Mar 2020 (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.
The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). In terms of exploring new diagnostic tools of sepsis, monocyte distribution width (MDW) was first reported in 2017. It was reported as part of the white blood cell (WBC) differential count. MDW greater than 20 and abnormal WBC count together were reported to provide a satisfactory accuracy. The area under curve (AUC) in predicting sepsis-2 is 0.852. It was proposed as a novel diagnostic tool of sepsis in the emergency setting. Nonetheless, the performance of MDW compared with the conventional biomarkers remained unknown. The aim of this study was to compare the diagnostic accuracy of MDW and PCT on sepsis in the emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-infection | – | Diagnostic Test: Monocyte Distribution Width |
| Infection without sepsis | – | Diagnostic Test: Monocyte Distribution Width |
| Sepsis-2 | – | Diagnostic Test: Monocyte Distribution Width |
| Sepsis-3 | – | Diagnostic Test: Monocyte Distribution Width |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on a target of 75% sensitivity and lower limit of 65%, a minimum of 63 (will target 100) septic patients would be required. Higher numbers may be enrolled in the study to ensure adequate representation of sepsis cases. Given the estimated prevalence of the disease in the emergency department population (5-10%%), the number of non-septic patients is predicted to be significantly higher than septic. Based on the estimated prevalence of subjects who present and have blood draw, a minimum of 100 non-septic cases will be collected.
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 |
|---|---|---|
| Monocyte Distribution WidthMonocyte Distribution Width as part of the CBC result. | Diagnostic test | Infection without sepsis, Non-infection, Sepsis-2, Sepsis-3 |
Primary outcome
Sensitivity and specificity of predicting sepsis and sepsis-3 patients
Time frame: within 2 hours after patient arrived ED.
MDW, PCT, and other laboratory tests were all obtained at the same time with 2 hours after the patient was admitted to the emergency department (ED). Sensitivity and specificity of different cutoff value were calculated. Best cutoff value will be decided by the perfomance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 34983430Li CH, Seak CJ, Chaou CH, Su TH, Gao SY, Chien CY, Ng CJ. Comparison of the diagnostic accuracy of monocyte distribution width and procalcitonin in sepsis cases in the emergency department: a prospective cohort study. BMC Infect Dis. 2022 Jan 4;22(1):26. doi: 10.1186/s12879-021-06999-4.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chih-huang Li, MD principal investigator
Chang Gung Memorial Hospital, Linkou Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Diagnoses Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-huang Li, MD (0975360718, chhli2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of predicting sepsis and sepsis-3 patients (time frame: within 2 hours after patient arrived ED.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322942, which also lists 1 linked publication.
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 26 Mar 2020.