Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-04 @ 2:16 AM
Study NCT ID:
NCT00825357
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2009-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Markers to Identify Early Sepsis and Acute Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], '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': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage.", 'timeFrame': '72 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biological markers', 'sepsis', 'acute lung injury'], 'conditions': ['Sepsis', 'Acute Lung Injury']}, 'descriptionModule': {'briefSummary': "There are no clear markers to identify sepsis and acute lung injury at early stage in clinical settings which would result in improved survival of the patients. In collaboration with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular diseases in ICU patients. These findings may provide valuable information for therapeutic guideline in clinical practice. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury. We will examine the roles of three components of markers including inflammation, neutrophil activation and coagulation. We are hoping that this proposed translational research will help develop novel therapeutic strategy in sepsis and acute lung injury patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to ICU and age ≧18-year-old.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet diagnostic criteria of ≧2 SIRS or acute lung injury.\n* Get agreement of patient's attending physician and inform consent form patient or family.\n\nExclusion Criteria:\n\n* Use Antibiotics over 24 hrs（only SIRS group）.\n* Active bleeding.\n* Pregnancy.\n* Active Cancer (refer to malignancy which is recently diagnosed, under treatment, or relapsed)\n* VS or Subject or Family refuse"}, 'identificationModule': {'nctId': 'NCT00825357', 'briefTitle': 'Biological Markers to Identify Early Sepsis and Acute Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'Chimei Medical Center'}, 'orgStudyIdInfo': {'id': 'CM-IRB09509002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Department of Intensive Care Medicine; Chi Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chimei Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief', 'investigatorFullName': 'Kuo-Chen Cheng', 'investigatorAffiliation': 'Chimei Medical Center'}}}}