Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03372330
Other study ID # 106-044-E
Secondary ID
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
Health authority
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:

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3