- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610020
Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity
November 5, 2022 updated by: Omar Hamdy, Ain Shams University
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
Study Overview
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minya, Egypt, 61511
- Omar Hamdy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adult confirmed septic patients
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Any pregnancy female
- Any patient who is Neutropenic secondary to malignancy
- Patients who is taking immunosuppressive therapy
- Patients who is suffering fromHematological malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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72 hours after meeting sepsis ceriteria
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heparin binding protein and mortality
Time Frame: 28 days after meeting sepsis ceriteria
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Correlates the change of the level of Heparin binding protein in ng/ml And how can it is used to predict mortality
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28 days after meeting sepsis ceriteria
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
October 1, 2022
Study Registration Dates
First Submitted
October 20, 2022
First Submitted That Met QC Criteria
November 5, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 5, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU M D 159/ 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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