Investigation of Plasma Mitochondrial DNA Level in Septic Patients

Plasma Levels of Mitochondrial DNA in Patients Presenting to ICU With Sepsis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02019992

Enrollment

Registered

2013-12-24

Start date

2013-09-30

Completion date

2015-02-28

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Sepsis

Keywords

sepsis, mitochondrial DNA, systemic inflammation, outcome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary Contactlemeng zhang, md

8673185064389

Backup Contactyuhang ai, ma

8673184327074

Outcome results