An observational study in Peripheral Artery Disease, Peripheral Artery Occlusion and Sepsis, sponsored by National Taiwan University Hospital Hsin-Chu Branch. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by National Taiwan University Hospital Hsin-Chu Branch · Observational
Among 26 studies in Peripheral Arterial Disease with a site in Taiwan — 8 open to participants now, 8 under way, 3 of them phase 3. Peripheral Arterial Disease · Taiwan.
Among the 26 studies in Peripheral Arterial Disease with a site in Taiwan, this one is one of 2 that started in 2017, is one of 5 observational ones, and was the 10th registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 200 is close to the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →8 of the 26 studies in Peripheral Arterial Disease with a site in Taiwan are open now, in 12 countries. Each count lists the studies.
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2017.
Median enrollment 212 across the 21 interventional studies, 230 across the 5 observational. Of the 11 that completed or were terminated, 4 (36%) have results posted.
10 of 26 have an industry lead sponsor. The 10 most frequent:
National Taiwan University Hospital Hsin-Chu Branch is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
National Taiwan University Hospital Hsin-Chu Branch has 1 study filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Peripheral Arterial Disease with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04511247Concept Medical Inc.SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease | 2026-12 |
Among the 26 studies in Peripheral Arterial Disease with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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).
Patients admitted to the medical intensive care units meeting sepsis definition.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 medications care for the patient with PAD included antiplatelet agents.
Also known as: Sepsis with PAD
The standard care for the patient with sepsis.
Also known as: Sepsis without PAD
All-cause mortality at 30-day
All-cause mortality at 30 days
Time frame: 30 days
Myocardial infarction
Myocardial infarction at 30 days
Time frame: 30 days
Stroke
Ischemic stroke at 30 days
Time frame: 30 days
Amputation
Amputation, either major or minor at 30 days
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2017 (actual). Primary completion is estimated for Sep 2018, 11 months after the start.
Of 138 non-industry observational studies under Peripheral Arterial Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 11 months is below that.
Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital Hsin-Chu Branch