Peripheral Artery Disease and Sepsis Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective observational study focusing on peripheral artery disease (PAD) in patients admitting to intensive care units with a diagnosis of sepsis. The sepsis is defined by the quick SOFA score. The primary outcome is all-cause mortality. The secondary outcomes included stroke, myocardial infarction, amputation, and prolonged mechanical ventilation. 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).

Official Title
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Prevalence and Outcomes of Peripheral Artery Disease in Sepsis Patients in the Medical Intensive Care Unit

Conditions
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Peripheral Artery Disease, Peripheral Artery Occlusion, Sepsis, Diagnosis

Intervention / Treatment
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* Drug: Standard care for sepsis and PAD
* Drug: Standard care for sepsis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sepsis patients admitted to the MICU meeting quick SOFA score >= 2 points Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis with PAD<br>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 | Drug: Standard care for sepsis and PAD<br>* The standard medications care for the patient with PAD included antiplatelet agents.<br>* Other names: Sepsis with PAD;|
| Sepsis without PAD<br>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 | Drug: Standard care for sepsis<br>* The standard care for the patient with sepsis.<br>* Other names: Sepsis without PAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 30-day | All-cause mortality at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | Myocardial infarction at 30 days | 30 days | 
| Stroke | Ischemic stroke at 30 days | 30 days | 
| Amputation | Amputation, either major or minor at 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral artery disease, sepsis