SepsisNCT04767893
Diagnostic and Prognostic Biomarkers of Sepsis
An observational study of Sepsis, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Sepsis
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2019to 28 Dec 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 19 to 70 years
- All sexes
- Adult, Older adult
Study population: Our study was conducted on patients admitted to different ICUs in Sohag University Hospital who develop possible clinical signs of sepsis
Who may be able to join
- Temperature of >38oC
- Heart rate of >90 beats/min
- Respiratory rate of >20 breaths/min
- Partial pressure of arterial carbon dioxide (PaCO2) of <32 mmHg
- White blood cell (WBC) count of >12,000 cells/mm3
Who cannot join
- HIV patients
- Patients with neutropenia <1000 cells/mm3
- <18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients
This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.
Read the detailed description
Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients
- Conditions
- Sepsis
- Keywords
- sTREM-1, sUPAR, CRP
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
by ELISA"enzyme linked immunosorbent assay"
Measured: in the 1st day after appearance of clinical signs of infection
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
by ELISA"enzyme linked immunosorbent assay"
Measured: in the 7th day after appearance of clinical signs of infection
Measurement of the serum level of sUPAR (ng/L) in the ICU patients
by ELISA"enzyme linked immunosorbent assay"
Measured: in the 1st day after appearance of clinical signs of infection
Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS
by ELISA"enzyme linked immunosorbent assay"
Measured: in the 7th day after appearance of clinical signs of infection
Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
by turbidimetry
Measured: in the 1st day after appearance of clinical signs of infection
Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
by turbidimetry
Measured: in the 7th day after appearance of clinical signs of infection
Secondary outcomes (2)
Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS
an integer score from 0 to 71
Measured: in the 7th day after appearance of clinical signs of infection
The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS
0-<11
Measured: in the 7th day after appearance of clinical signs of infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start14 Jun 2019
- Primary completion1 Dec 2020
- Study completion28 Dec 2020
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 Sohag UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahed Fathallah Fahmy, Sohag University
- Investigators
- Nahed Fathallah, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767893
- Sponsor's protocol ID
- Soh-Med-21-02-18
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients
- ClinicalTrials.gov ID
- NCT04767893
- Acronym / sponsor ID
- Soh-Med-21-02-18
- Conditions
- Sepsis
- Keywords
- sTREM-1, sUPAR, CRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 23 Feb 2021 (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.
This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.
Detailed description
Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Our study was conducted on patients admitted to different ICUs in Sohag University Hospital who develop possible clinical signs of sepsis
Key inclusion criteria (5 listed)
- Temperature of >38oC
- Heart rate of >90 beats/min
- Respiratory rate of >20 breaths/min
- Partial pressure of arterial carbon dioxide (PaCO2) of <32 mmHg
- White blood cell (WBC) count of >12,000 cells/mm3
Key exclusion criteria (3 listed)
- HIV patients
- Patients with neutropenia <1000 cells/mm3
- <18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
Time frame: in the 1st day after appearance of clinical signs of infection
by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
Time frame: in the 7th day after appearance of clinical signs of infection
by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of sUPAR (ng/L) in the ICU patients
Time frame: in the 1st day after appearance of clinical signs of infection
by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS
Time frame: in the 7th day after appearance of clinical signs of infection
by ELISA"enzyme linked immunosorbent assay"
Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
Time frame: in the 1st day after appearance of clinical signs of infection
by turbidimetry
Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
Time frame: in the 7th day after appearance of clinical signs of infection
by turbidimetry
2 secondary outcomes
Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS
Time frame: in the 7th day after appearance of clinical signs of infection
The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS
Time frame: in the 7th day after appearance of clinical signs of infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Related trials for Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Nahed Fathallah, lecturer principal investigator
Sohag University
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, run by Sohag University at 1 site in Egypt.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS (time frame: in the 1st day after appearance of clinical signs of infection). The study lists 6 primary outcomes in all. 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 23 Feb 2021.