Peripheral Artery Disease and Sepsis Outcomes
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|ClinicalTrials.gov Identifier: NCT03372330|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
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.
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease Peripheral Artery Occlusion Sepsis Diagnosis||Drug: Standard care for sepsis and PAD Drug: Standard care for sepsis|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Prevalence and Outcomes of Peripheral Artery Disease in Sepsis Patients in the Medical Intensive Care Unit|
|Actual Study Start Date :||September 11, 2017|
|Estimated Primary Completion Date :||September 10, 2018|
|Estimated Study Completion Date :||September 10, 2019|
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
Drug: Standard care for sepsis and PAD
The standard medications care for the patient with PAD included antiplatelet agents.
Other Name: Sepsis with PAD
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
Drug: Standard care for sepsis
The standard care for the patient with sepsis.
Other Name: Sepsis without PAD
- All-cause mortality at 30-day [ Time Frame: 30 days ]All-cause mortality at 30 days
- Myocardial infarction [ Time Frame: 30 days ]Myocardial infarction at 30 days
- Stroke [ Time Frame: 30 days ]Ischemic stroke at 30 days
- Amputation [ Time Frame: 30 days ]Amputation, either major or minor at 30 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372330
|Contact: Mu-Yang Hsieh, MDfirstname.lastname@example.org|
|National Taiwan University Hospital, Hsin-Chu Branch||Recruiting|
|Hsinchu, Taiwan, 300|
|Contact: Mu-Yang Hsieh, MD 886-972-654046 email@example.com|
|Contact: Ren-Huei Wang, RN 886-35-326151 ext 2009 CRN740628@gmail.com|
|Principal Investigator:||Mu-Yang Hsieh, MD||National Taiwan University Hospital Hsin-Chu Branch|