Peripheral Artery Disease and Sepsis Outcomes

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372330
• Other study ID #: 106-044-E
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2017
• Last updated: December 10, 2017
• Start date: September 11, 2017
• Est. completion date: September 10, 2019

Study information

• Verified date: December 2017
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Mu-Yang Hsieh, MD
• Phone: 886-972654046
• Email: drake1128[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Diagnosis
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Artery Occlusion
• Sepsis
• Toxemia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality at 30-day	All-cause mortality at 30 days	30 days
Secondary	Myocardial infarction	Myocardial infarction at 30 days	30 days
Secondary	Stroke	Ischemic stroke at 30 days	30 days
Secondary	Amputation	Amputation, either major or minor at 30 days	30 days