SepsisNCT05610020
Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity
An observational study of Sepsis and HBP, run by Ain Shams University at 1 site in Egypt.
Trial summary
the aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis Read more about this study
- Who is it for?
- Ages 20 to 70 years
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Oct 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult confirmed septic patients
Who may be able to join
- adult whose age between 20 to70 years old
- patients suffered from sepsis or septic shock (under the third international consensus definition of sepsis and septic shock)
Who cannot join
- Any pregnancy female
- Any patient who is Neutropenic secondary to malignancy
- Patients who is taking immunosuppressive therapy
- Patients who is suffering fromHematological malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin Binding Protein as a Reliable Prognostic Biomarker for Severity of Sepsis in the Intensive Care Unit
the aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the level of Heparin binding protein in relation to patient clinical improvement measured by SOFA Score
Correlates the change of the level of Heparin binding protein in ng/ml to the clinical improvement of the patients which is measured by SOFA score
Measured: 72 hours after meeting sepsis ceriteria
Secondary outcomes (1)
Heparin binding protein and mortality
Correlates the change of the level of Heparin binding protein in ng/ml And how can it is used to predict mortality
Measured: 28 days after meeting sepsis ceriteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2021
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
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 Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610020
- Sponsor's protocol ID
- FMASU M D 159/ 2021
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Binding Protein as a Reliable Prognostic Biomarker for Severity of Sepsis in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05610020
- Acronym / sponsor ID
- FMASU M D 159/ 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Nov 2022 (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 aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult confirmed septic patients
Key inclusion criteria (2 listed)
- adult whose age between 20 to70 years old
- patients suffered from sepsis or septic shock (under the third international consensus definition of sepsis and septic shock)
Key exclusion criteria (4 listed)
- Any pregnancy female
- Any patient who is Neutropenic secondary to malignancy
- Patients who is taking immunosuppressive therapy
- Patients who is suffering fromHematological malignancy
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
Evaluate the level of Heparin binding protein in relation to patient clinical improvement measured by SOFA Score
Time frame: 72 hours after meeting sepsis ceriteria
Correlates the change of the level of Heparin binding protein in ng/ml to the clinical improvement of the patients which is measured by SOFA score
1 secondary outcome
Heparin binding protein and mortality
Time frame: 28 days after meeting sepsis ceriteria
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 8 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HBP, run by Ain Shams 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 2 inclusion and 4 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 8 Nov 2022. 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?
Evaluate the level of Heparin binding protein in relation to patient clinical improvement measured by SOFA Score (time frame: 72 hours after meeting sepsis ceriteria). 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 8 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.