Investigation of Plasma Mitochondrial DNA Level in Septic Patients

• Conditions: Sepsis; Inflammation

• Registration Number: NCT02019992
• Lead Sponsor: Central South University

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.

Detailed Description

Clinical protocol:

Patients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response.

Methods:

Plasma levels of mtDNAs were measured using real-time quantitative polymerase chain reaction. Levels of mtDNAs were compared among each group, and linear regression was used to assess the association between mtDNAs, IL-6, TNF a and IL-1b in patients with sepsis. The correlation between plasma mtDNA and severity, systemic inflammation and outcomes will be analyzed.

Study Timeline

• Study Start: 2013-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-18
• Last Update Submitted: 2013-12-18
• Study First Posted: 2013-12-24
• Last Update Posted: 2013-12-24
• Primary Completion: 2015-01
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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"

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days	7 days	The change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days will be measured by ELISA.

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China