Investigation of Plasma Mitochondrial DNA Level in Septic Patients

NCT02019992 | Unknown DMC

• 1 other identifier: CSU-ICU-2013-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the plasma levels of mtDNA in ICU department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. Plasma from control, septic and severe septic patients will be collected. The level of mtDNA and systemic cytokine will be measured.

Conditions

Sepsis; Inflammation

Keywords

sepsis; mitochondrial DNA; systemic inflammation; outcome

Outcome Measures

Primary Outcomes (1)

• change from baseline in plasma mtDNA in septic patients at 7 days

  The change from baseline in plasma mtDNA in septic patients at 7 days will be measured by real-time PCR.

  7 days

Secondary Outcomes (1)

• change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days

  7 days

Study Arms (3)

sepsis

sepsis defined as suspected infection and systemic inflammatory response

severe sepsis

sepsis with organ dysfunction or septic shock defined as sepsis plus hypotension

control group

control defined as non-infected patients without systemic inflammatory response.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sepsis and severe septic patients enrolled in 2014 will be collected.

You may qualify if:

• Diagnosis of sepsis and severe sepsis was according to the following guild-line. "Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012"

You may not qualify if:

• Patients lost following-up. Patients who refuse to sign the consent form.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Sepsis; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• lemeng zhang, md

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lemeng zhang, md

CONTACT

8673185064389

yuhang ai, ma

CONTACT

8673184327074

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 24, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

CN (1)