Myeloid-derived Suppressor Cells in Sepsis

The Roles of MDSCs (Myeloid-derived Suppressor Cells) in Adult Patients With Sepsis.

This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.

Study Overview

• Status: Recruiting
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Fu-Tsai Chung, MD; Phone Number: 8468 +886-3281200; Email: vikingchung@yahoo.com.tw

Study Locations

• Taiwan
  • Linkou, Taiwan, 333
    • Recruiting
    • Chung Gung Memorial Hospital
    • Contact: Fu-Tsai Chung, MD; Phone Number: 8468 +886-3-3281200; Email: vikingchung@yahoo.com.tw
    • Principal Investigator: Fu-Tsai Chung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will include patients admitted with diagnosis of sepsis in this study.

Sepsis is defined by the consensus committee of American College of Chest Physicians and Society of Critical Care Medicine. The investigators will interview each patient and their family members, and review the medical records to obtain the baseline information including demographic data, clinical diagnosis, and evidence of dementia or psychiatric disorders. Acute physical and chronic health evaluation (APACHE II) score will be rated by chart review of data obtained within 24 hours of admission. The underlying medical history will also be collected.

Description

Inclusion Criteria:

• Patients must have known origin of infection .
• Systemic inflammatory response syndrome.

Exclusion Criteria:

• age less than 18 years
• pregnancy
• known anaphylactoid reaction to colloid fluids
• a life expectancy less than 24 hours,
• inability to provide informed, written consent
• Patients receiving nephrotoxic drugs,
• admitted to the hospital following a surgical procedure,
• sepsis more than 72 hours when screening .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intensive care unit (ICU) patients with sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival of Intensive care unit (ICU) stay	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
In hospital survival	90 days

Collaborators and Investigators

• Sponsor: Chung Fu-Tsai

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: IRB103-6424B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No