Peripheral Artery Disease and Sepsis Outcomes

NCT03372330 | Unknown

• 1 other identifier: 106-044-E
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease; Peripheral Artery Occlusion; Sepsis; Diagnosis

Keywords

peripheral artery disease; sepsis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 30-day

  All-cause mortality at 30 days

  30 days

Secondary Outcomes (3)

• Myocardial infarction

  30 days

• Stroke

  30 days

• Amputation

  30 days

Study Arms (2)

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

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

Interventions

Standard care for sepsis and PAD DRUG

The standard medications care for the patient with PAD included antiplatelet agents.

Also known as: Sepsis with PAD

Sepsis with PAD

Standard care for sepsis DRUG

The standard care for the patient with sepsis.

Also known as: Sepsis without PAD

Sepsis without PAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, 300, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 39308652 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Sepsis; Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mu-Yang Hsieh, MD

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu-Yang Hsieh, MD

CONTACT

886-972654046; drake1128@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 13, 2017
• Study Start: September 11, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2019
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)