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Investigation of Plasma Mitochondrial DNA Level in Septic Patients

NCT ID: NCT02019992

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Sepsis Inflammation

Keywords

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sepsis mitochondrial DNA systemic inflammation outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sepsis

sepsis defined as suspected infection and systemic inflammatory response

No interventions assigned to this group

severe sepsis

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

No interventions assigned to this group

control group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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lemeng zhang

md

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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lemeng zhang, md

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

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Xiangya Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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lemeng zhang, md

Role: CONTACT

Phone: 8673185064389

yuhang ai, ma

Role: CONTACT

Phone: 8673184327074

Facility Contacts

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lemeng zhang, md

Role: primary

yuhang ai, md

Role: backup

Other Identifiers

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CSU-ICU-2013-01

Identifier Type: -

Identifier Source: org_study_id