NCT03540797

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

8.5 years

First QC Date

May 17, 2018

Last Update Submit

May 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival of Intensive care unit (ICU) stay

    28 days

Secondary Outcomes (1)

  • In hospital survival

    90 days

Study Arms (1)

Intensive care unit (ICU) patients with sepsis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Gung Memorial Hospital

Linkou District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Fu-Tsai Chung, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

July 1, 2015

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations