Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.NCT02883231
Plasma Level of Mitochondrial DNA in Patients With ARDS and Its Clinical Significance
An observational study of Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS., run by Chun Pan at 1 site in China.
Trial summary
To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and to explore its clinical significance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.
- What is being tested?
- taking peripheral blood
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS。
Who may be able to join
- Patients admitted to ICU diagnosed of ARDS (Berlin criteria),
- Patients age between 18 years old and 80 years.
Who cannot join
- Pregnant women,
- Patients with malignant tumor,
- Immunosuppression or immunocompromised patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Lili Huang, Dr, 13770840246, caowangyou007@126.com
Lili Huang, Dr
About this study
To observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and to explore its clinical significance.
Read the detailed description
60 patients who diagnosed as ARDS were included in this study.Then keep blood samples from these patients in the first day、the third day and the sveventh day,detect the mitochotndrial DNA level in plasma by real-time quantitative PCR. Recored Severity of illness and survival status of every patient within 28 days.Objective to evaluate the correlation between the level of mitochondrial DNA in plasma and the prognosis of the patients.
- Being tested
- taking peripheral blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking peripheral bloodOther
taking peripheral blood of no more than 3ml
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chun Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883231
- Sponsor's protocol ID
- ARDS mtDNA
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Peng F, Liang C, Chang W, Sun Q, Xie J, Qiu H, Yang Y. Prognostic Significance of Plasma Hepatocyte Growth Factor in Sepsis. J Intensive Care Med. 2022 Mar;37(3):352-358. doi: 10.1177/0885066621993423. Epub 2021 Feb 22.
PubMed 33611982
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Level of Mitochondrial DNA in Patients With ARDS and Its Clinical Significance
- ClinicalTrials.gov ID
- NCT02883231
- Acronym / sponsor ID
- ARDS mtDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chun PanUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 30 Aug 2016 (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 observe the changes of plasma mitochondrial DNA (mtDNA) levels in patients with ARDS, and to explore its clinical significance.
Detailed description
60 patients who diagnosed as ARDS were included in this study.Then keep blood samples from these patients in the first day、the third day and the sveventh day,detect the mitochotndrial DNA level in plasma by real-time quantitative PCR. Recored Severity of illness and survival status of every patient within 28 days.Objective to evaluate the correlation between the level of mitochondrial DNA in plasma and the prognosis of the patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS。
Key inclusion criteria (2 listed)
- Patients admitted to ICU diagnosed of ARDS (Berlin criteria),
- Patients age between 18 years old and 80 years.
Key exclusion criteria (3 listed)
- Pregnant women,
- Patients with malignant tumor,
- Immunosuppression or immunocompromised patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking peripheral bloodtaking peripheral blood of no more than 3ml | Other | – |
Primary outcome
mortality
Time frame: 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 33611982Peng F, Liang C, Chang W, Sun Q, Xie J, Qiu H, Yang Y. Prognostic Significance of Plasma Hepatocyte Growth Factor in Sepsis. J Intensive Care Med. 2022 Mar;37(3):352-358. doi: 10.1177/0885066621993423. Epub 2021 Feb 22.
- Individual participant dataSharing planned: No
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.
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 Evaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS., run by Chun Pan 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 2 inclusion and 3 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 30 Aug 2016. 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 Lili Huang, Dr (13770840246, caowangyou007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883231, which also lists 1 linked publication.
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 30 Aug 2016.