Dendritic Cells-Derived Exosomes in Human Sepsis

NCT02957279 | Unknown DMC

• 1 other identifier: 20161103
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

Conditions

Sepsis

Keywords

sepsis; exosomes; dendritic cell

Outcome Measures

Primary Outcomes (1)

• Amount of dendritic cell-derived exosomes

  The first 4 hour after admission

Secondary Outcomes (1)

• Compositions of microRNA in the dendritic cell-derived exosomes

  The first 4 hour after admission

Study Arms (2)

Sepsis group

The patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0).

Drug: Antibiotics

Healthy control group

Healthy volunteers.

Interventions

Antibiotics DRUG

In the sepsis group, antibiotics were used when needed.

Sepsis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were admitted to Jinling Hospital from November, 2016.

You may qualify if:

• Patients were selected with the diagnostic standard "Sepsis 3.0".
• Healthy volunteers do not have serious illness.

You may not qualify if:

• Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
• Patients give up treatments.
• Patients or volunteers withdrew from the study.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral venous blood

MeSH Terms

Conditions

Sepsis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jianan Ren, MD

  Jinling Hospital, Medical School of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianan Ren, MD

CONTACT

862580860108; jiananr@gmail.com

Yuan Li, MD

CONTACT

8615751866716; liyuan9006@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of department of surgery, Jinling Hospital

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

CN (1)