SepsisNCT02019992
Investigation of Plasma Mitochondrial DNA Level in Septic Patients
An observational study of Sepsis and Inflammation, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Inflammation
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sepsis and severe septic patients enrolled in 2014 will be collected.
Who may be able to join
- 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"
Who cannot join
- Patients lost following-up. Patients who refuse to sign the consent form.
Trial locations and contacts
1 site in 1 country.
lemeng zhang, md contact
yuhang ai, ma contact
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital
Changsha, Hunan, 410000
lemeng zhang, md, 8673185064389
yuhang ai, md, 8673284327974
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Inflammation
- Keywords
- sepsis, mitochondrial DNA, systemic inflammation, outcome
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lemeng zhang, Central South University
- Investigators
- lemeng zhang, md, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019992
- Sponsor's protocol ID
- CSU-ICU-2013-01
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Mitochondrial DNA in Patients Presenting to ICU With Sepsis
- ClinicalTrials.gov ID
- NCT02019992
- Acronym / sponsor ID
- CSU-ICU-2013-01
- Conditions
- Sepsis, Inflammation
- Keywords
- sepsis, mitochondrial DNA, systemic inflammation, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis and severe septic patients enrolled in 2014 will be collected.
Key inclusion criteria (1 listed)
- 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"
Key exclusion criteria (1 listed)
- Patients lost following-up. Patients who refuse to sign the consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lemeng zhang, md contact
yuhang ai, ma contact
lemeng zhang, md principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Inflammation, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lemeng zhang, md (8673185064389), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in plasma mtDNA in septic patients at 7 days (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.