Intensive Care UnitNCT04083482
Removal of mtDNA in Plasma by Continous Venovenous Hemofiltration in Sepsis
A study testing continous venovenous hemofiltraion in people with Intensive Care Unit, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
The plasma level of mtDNA in sepsis is affected by continous venovenous hemofiltation（CVVH） Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- continous venovenous hemofiltraion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult septic patients undergoing CRRT
Who cannot join
- Missing vists
- transplatation
- cancer
- aquired immunodeficiency syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The plasma level of mtDNA in sepsis is affected by continous venovenous hemofiltation（CVVH）
Read the detailed description
Continous renal replacement therapy （CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .In clinical patients ，continous venovenous hemofoiltration （CVVH）is actually the method of chioce for CRRT in critically ill and hemodynamic instable patients .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index，increasing cardiac index and regulating immune dysfuntion .
- Conditions
- Intensive Care Unit
- Being tested
- continous venovenous hemofiltraion
- Keywords
- Mitochondrial DNA, Sepsis, Continous venovenous hemofiltation, Intensive Care Unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continous venovenous hemofiltraionProcedure or surgery
CVVH
| Study group | Role | What they receive |
|---|---|---|
| Septic patients require CVVH | Experimental | continuous venovenous hemofiltration. Continuous renal replacement therapy（CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .Continuous venovenous hemofiltration（CVVH）is the method of chioce for CRRT in critical ill .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index ，decreasing vasopressor requirements，increasing cardiac index and regulating immune dysfunction . Receives: Procedure: continous venovenous hemofiltraion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mtDNA concentration in plasma
The specimens in the prefilter and postfilter blood as well as in the ultrafiltrate were obtained at the beginning of CRRT (T0) and 6 h (T6h), 12 h (T12h) after the setup of CVVH.
Measured: befor,6hours, 12hours, after CVVH treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start20 Aug 2018
- Primary completion20 Sep 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingui Dai, First People's Hospital of Chenzhou
- Investigators
- dixian luo, MS, Study director, Chenzhou First people Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083482
- Sponsor's protocol ID
- WYJ2019
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of mtDNA in Plasma by Continous Venovenous Hemofiltration in Sepsis
- ClinicalTrials.gov ID
- NCT04083482
- Acronym / sponsor ID
- WYJ2019
- Conditions
- Intensive Care Unit
- Keywords
- Mitochondrial DNA, Sepsis, Continous venovenous hemofiltation, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 Sep 2019 (actual)
- 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.
The plasma level of mtDNA in sepsis is affected by continous venovenous hemofiltation（CVVH）
Detailed description
Continous renal replacement therapy （CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .In clinical patients ，continous venovenous hemofoiltration （CVVH）is actually the method of chioce for CRRT in critically ill and hemodynamic instable patients .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index，increasing cardiac index and regulating immune dysfuntion .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic patients require CVVH | Experimental | Procedure: continous venovenous hemofiltraioncontinuous venovenous hemofiltration. Continuous renal replacement therapy（CRRT）has become routine for patients with chronic renal failure ，AKI，fliud overload as well as oliguria in ICU .Continuous venovenous hemofiltration（CVVH）is the method of chioce for CRRT in critical ill .CVVH has significant beneficial effects on removing inflammatory cytokines ，improving oxygen index ，decreasing vasopressor requirements，increasing cardiac index and regulating immune dysfunction . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult septic patients undergoing CRRT
Key exclusion criteria (4 listed)
- Missing vists
- transplatation
- cancer
- aquired immunodeficiency syndrome
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 |
|---|---|---|
| continous venovenous hemofiltraionCVVH | Procedure or surgery | Septic patients require CVVH |
Primary outcome
Change of mtDNA concentration in plasma
Time frame: befor,6hours, 12hours, after CVVH treatment
The specimens in the prefilter and postfilter blood as well as in the ultrafiltrate were obtained at the beginning of CRRT (T0) and 6 h (T6h), 12 h (T12h) after the setup of CVVH.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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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.
dixian luo, MS study director
Chenzhou First people Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continous venovenous hemofiltraion in people with Intensive Care Unit, run by First People's Hospital of Chenzhou 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 4 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 10 Sep 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mtDNA concentration in plasma (time frame: befor,6hours, 12hours, after CVVH treatment). 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 10 Sep 2019.