Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-09-11
2019-09-10
Brief Summary
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We conducted a prospective cohort study focusing on patients admitted to the MICU with the main diagnosis of sepsis. The ankle-brachial indexes are performed within 24 hours after admission. Invasive arterial line monitoring and standard non-invasive measurements are collected. After confirmation of PAD, standard anti-platelet treatments (aspirin and cilostazol) are initiated. The survival before and after the conduction of this trial is compared to historical records. The outcomes including all-cause mortality, stroke, myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent are to be collected.
Detailed Description
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We plan to enroll 150 patients. Patients will be grouped into patients with PAD and patients without PAD. We then compare them in the following parameters: clinical data, laboratory data, survival and other outcome data. Two-sample student's t-tests will be used for the comparisons of continuous variables. Chi-square test will be used to detect the difference between categorical variables. The difference is considered statistically significant if P \< 0.05. All statistics works were analyzed using the SPSS 17.0 software (Chicago, IL, USA), R software (Gimc packages).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sepsis with PAD
Patients admitted to the intensive care unit with the diagnosis of sepsis (quick SOFA score \>=2) and with ankle-brachial index \< 0.9 or vascular Duplex confirmed peripheral artery disease.
\* Standard care for sepsis and PAD
Standard care for sepsis and PAD
The standard medications care for the patient with PAD included antiplatelet agents.
Sepsis without PAD
Patients admitted to the intensive care unit with the diagnosis of sepsis (quick SOFA score \>=2) and with ankle-brachial index \>= 0.9 or vascular Duplex found no evidence of peripheral artery disease.
\* Standard care for sepsis
Standard care for sepsis
The standard care for the patient with sepsis.
Interventions
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Standard care for sepsis and PAD
The standard medications care for the patient with PAD included antiplatelet agents.
Standard care for sepsis
The standard care for the patient with sepsis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital Hsin-Chu Branch
OTHER
Responsible Party
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Principal Investigators
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Mu-Yang Hsieh, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital Hsin-Chu Branch
Locations
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National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Mu-Yang Hsieh, MD
Role: primary
Ren-Huei Wang, RN
Role: backup
References
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Tseng H, Liao MT, Keng LT, Chang CH, Zeng YZ, Hsieh MY. Impact of Abnormal Ankle Brachial Index on Sepsis Survival: One-Year Prospective Study Results. Acta Cardiol Sin. 2024 Sep;40(5):627-634. doi: 10.6515/ACS.202409_40(5).20240528A.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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106-044-E
Identifier Type: -
Identifier Source: org_study_id