Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT07060560
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presepsin Diagnostic Performance in Severe Burn Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}, 'targetDuration': '4 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients', 'timeFrame': 'Up to 2 hours after initial clinical suspicion of sepsis.', 'description': 'The proportion of true-positive and true-negative presepsin results for diagnosing sepsis using Sepsis-3 clinical criteria and positive blood culture as the reference standard.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Burns']}, 'descriptionModule': {'briefSummary': "This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A prospective cohort of adult (≥ 18 years) patients with severe burns (TBSA ≥ 20 %) admitted to the Burn Intensive Care Unit at Hangang Sacred Heart Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥ 18 years admitted to Hangang Sacred Heart Hospital Burn ICU with total body surface area (TBSA) ≥ 20 %\n* Clinical suspicion of sepsis prompting blood culture and biomarker sampling\n* Ability to understand the study and provide written informed consent (or via legally authorized representative)\n\nExclusion Criteria:\n\n* Inability to undergo research blood draw due to emergent surgery or major trauma at sampling time\n* Chronic immunosuppressive conditions (e.g., long-term high-dose steroids, organ transplant, congenital immunodeficiency)\n* Pregnant women or those with significant psychiatric conditions precluding consent\n* Any other medical or safety concerns deemed inappropriate by the investigator'}, 'identificationModule': {'nctId': 'NCT07060560', 'acronym': 'PSEP-BURNS', 'briefTitle': 'Presepsin Diagnostic Performance in Severe Burn Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Hangang Sacred Heart Hospital'}, 'officialTitle': 'Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients', 'orgStudyIdInfo': {'id': '2025-009'}}, 'contactsLocationsModule': {'locations': [{'zip': '07981', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ra Gyeom Seong', 'role': 'CONTACT', 'email': 'dohern@hallym.or.kr', 'phone': '01094157154'}, {'name': 'Dohern', 'role': 'CONTACT'}], 'facility': 'Hangang Sacred Heart Hospital, Hallym University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dohern Kym', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Burn Intensive Care Unit', 'investigatorFullName': 'Dohern Kym', 'investigatorAffiliation': 'Hangang Sacred Heart Hospital'}}}}