Peripheral Artery Disease and Sepsis Outcomes | NCT03372330

Studies
Peripheral Artery Disease and Sepsis Outcomes

NCT03372330

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Status

Unknown status

Last Update Posted

Dec 13, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Peripheral Artery Disease
Peripheral Artery Occlusion
Sepsis
Diagnosis

Interventions

Standard care for sepsis and PAD
Standard care for sepsis

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2017Actual

Primary Completion Date

Sep 10, 2018Estimated

Completion Date

Sep 10, 2019Estimated

First Submitted Date

Dec 10, 2017

First Submission Date that Met QC Criteria

Dec 10, 2017

First Posted Date

Dec 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2017

Last Update Posted Date

Dec 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Standard care for sepsis and PAD	Drug	The standard medications care for the patient with PAD included antiplatelet agents.	Sepsis with PAD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Myocardial infarction	Myocardial infarction at 30 days	30 days
Stroke	Ischemic stroke at 30 days	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mu-Yang Hsieh, MD	Contact	886-972654046		drake1128@gmail.com

Overall Officials

Name	Affiliation	Role
Mu-Yang Hsieh, MD	National Taiwan University Hospital Hsin-Chu Branch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital, Hsin-Chu Branch	Recruiting	Hsinchu		300	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39308652	Derived	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.

ID	Term
D058729	Peripheral Arterial Disease
D018805	Sepsis
D004194	Disease

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation