## Protocol Section
### Identification Module
**NCT ID:** NCT02957279

**Brief Title:** Dendritic Cells-Derived Exosomes in Human Sepsis

**Official Title:** A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis

#### Organization Study ID Info
**ID:** 20161103
#### Organization
**Class:** OTHER
**Full Name:** Jinling Hospital, China
### Status Module
#### Completion Date
**Date:** 2017-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2016-11-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-11

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2016-11-06
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-04
**Study First Submit QC Date:** 2016-11-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jinling Hospital, China

#### Responsible Party

**Investigator Affiliation:** Jinling Hospital, China

**Investigator Full Name:** Jianan Ren

**Investigator Title:** President of department of surgery, Jinling Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed Description:** This is a prospective, single-centered, clinical cohort study.

### Conditions Module

**Conditions:**

- Sepsis

**Keywords:**

- sepsis

- exosomes

- dendritic cell

### Design Module

#### Bio Spec

**Description:** peripheral venous blood

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Antibiotics

**Label:** Sepsis group

#### Arm Group 2

**Description:** Healthy volunteers.

**Label:** Healthy control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sepsis group

**Description:** In the sepsis group, antibiotics were used when needed.

**Name:** Antibiotics

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Amount of dendritic cell-derived exosomes

**Time Frame:** The first 4 hour after admission

#### Secondary Outcomes

**Measure:** Compositions of microRNA in the dendritic cell-derived exosomes

**Time Frame:** The first 4 hour after admission

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients were admitted to Jinling Hospital from November, 2016.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jiananr@gmail.com

**Name:** Jianan Ren, MD

**Phone:** 862580860108

**Role:** CONTACT

**Contact 2:**

**Email:** liyuan9006@gmail.com

**Name:** Yuan Li, MD

**Phone:** 8615751866716

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** jiananr@gmail.com

- **Name:** Jianan Ren, MD

- **Phone:** 862580860108

- **Role:** CONTACT

***Contact 2:***

- **Email:** liyuan9006@gmail.com

- **Name:** Yuan Li, MD

- **Phone:** 8615751866716

- **Role:** CONTACT

**Country:** China

**Facility:** Jinling Hospital, Medical School of Nanjing University

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 210002

#### Overall Officials

**Official 1:**

**Affiliation:** Jinling Hospital, Medical School of Nanjing University

**Name:** Jianan Ren, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M20864

- Name: Sepsis

- Relevance: HIGH

- As Found: Sepsis

- ID: M16869

- Name: Toxemia

- Relevance: HIGH

- As Found: Sepsis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018805

- Term: Sepsis

- ID: D000014115

- Term: Toxemia

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: HIGH

- As Found: Initial

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

### Misc Info Module

- Version Holder: 2024-05-24
