NCT03372330|Unknown
Peripheral Artery Disease and Sepsis Outcomes
Prevalence and Outcomes of Peripheral Artery Disease in Sepsis Patients in the Medical Intensive Care Unit
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Prevalence and Outcomes of Peripheral Artery Disease in Sepsis Patients in the Medical Intensive Care Unit
Sponsor study identifier
observational
200
1 country
1
Study Start
September 11, 2017
Actual (reported)Primary Completion
September 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 10, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The peripheral artery disease (PAD) prevalence is high in the elderly, the diabetic patients, and the patients receiving hemodialysis. To date, there is no guideline recommendation on the screening of PAD in patients admitted to the medical intensive care unit (MICU) for sepsis. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 10, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2017
Actual (reported)December 10, 2017
Actual (reported)December 13, 2017
Actual (reported)September 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 10, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
All-cause mortality at 30-day
All-cause mortality at 30 days
30 days
Myocardial infarction
30 days
Stroke
30 days
Amputation
30 days
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
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
The standard medications care for the patient with PAD included antiplatelet agents.
The standard care for the patient with sepsis.
Patients admitted to the medical intensive care units meeting sepsis definition.
Contact the study team to confirm eligibility.
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, 300, Taiwan
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.
Mu-Yang Hsieh, MD
National Taiwan University Hospital Hsin-Chu Branch
First Submitted
December 10, 2017
First Posted
December 13, 2017
Study Start
September 11, 2017
Actual (reported)Primary Completion
September 10, 2018
Estimated (date passed)SHOWME-PAD (Peripheral Artery Disease)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 10, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 13, 2017
Record last verified: 2017-12
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