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Peripheral Artery Disease and Sepsis Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372330
Recruitment Status : Unknown
Verified December 2017 by National Taiwan University Hospital Hsin-Chu Branch.
Recruitment status was:  Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital Hsin-Chu Branch

Study Description
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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.


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

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality at 30-day [ Time Frame: 30 days ]
    All-cause mortality at 30 days


Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction at 30 days

  2. Stroke [ Time Frame: 30 days ]
    Ischemic stroke at 30 days

  3. Amputation [ Time Frame: 30 days ]
    Amputation, either major or minor at 30 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the medical intensive care units meeting sepsis definition.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • NA
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mu-Yang Hsieh, MD 886-972654046 drake1128@gmail.com

Locations
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Taiwan
National Taiwan University Hospital, Hsin-Chu Branch Recruiting
Hsinchu, Taiwan, 300
Contact: Mu-Yang Hsieh, MD    886-972-654046    drake1128@gmail.com   
Contact: Ren-Huei Wang, RN    886-35-326151 ext 2009    CRN740628@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital Hsin-Chu Branch
Investigators
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Principal Investigator: Mu-Yang Hsieh, MD National Taiwan University Hospital Hsin-Chu Branch
  Study Documents (Full-Text)

Documents provided by National Taiwan University Hospital Hsin-Chu Branch:
Study Protocol and Statistical Analysis Plan  [PDF] September 11, 2017

More Information
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Additional Information:

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Responsible Party: National Taiwan University Hospital Hsin-Chu Branch
ClinicalTrials.gov Identifier: NCT03372330    
Other Study ID Numbers: 106-044-E
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital Hsin-Chu Branch:
peripheral artery disease
sepsis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Peripheral Arterial Disease
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases