Investigation of Plasma Mitochondrial DNA Level in Septic Patients

December 18, 2013 updated by: lemeng zhang, Central South University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Hospital
        • Contact:
          • lemeng zhang, md
          • Phone Number: 8673185064389
        • Contact:
          • yuhang ai, md
          • Phone Number: 8673284327974
        • Principal Investigator:
          • lemeng zhang, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in plasma mtDNA in septic patients at 7 days
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: lemeng zhang, md, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU-ICU-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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