Peripheral Artery Disease and Sepsis Outcomes

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Peripheral Artery Disease; Diagnosis; Peripheral Artery Occlusion
• Intervention / Treatment: Drug: Standard care for sepsis and PAD; Drug: Standard care for sepsis

Detailed Description

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
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Mu-Yang Hsieh, MD; Phone Number: 886-972654046; Email: drake1128@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • National Taiwan University Hospital, Hsin-Chu Branch
    • Contact: Mu-Yang Hsieh, MD; Phone Number: 886-972-654046; Email: drake1128@gmail.com
    • Contact: Ren-Huei Wang, RN; Phone Number: 2009 886-35-326151; Email: CRN740628@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the medical intensive care units meeting sepsis definition.

Description

Inclusion Criteria:

• sepsis patients admitted to the MICU meeting quick SOFA score >= 2 points

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: Sepsis without PAD

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch
• Investigators: Principal Investigator: Mu-Yang Hsieh, MD, National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Anticipated): September 10, 2018
• Study Completion (Anticipated): September 10, 2019

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 10, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: sepsis; peripheral artery disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Arteriosclerosis; Arterial Occlusive Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Atherosclerosis; Peripheral Vascular Diseases; Sepsis; Toxemia; Peripheral Arterial Disease
• Other Study ID Numbers: 106-044-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No