SepsisNCT00862290
Circulating microRNAs as Biomarkers of Sepsis
An observational study of Sepsis, run by Changhai Hospital at 1 site in China.
Trial summary
MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Jun 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who develop sepsis and SIRS
Who may be able to join
- patients who develop sepsis and undergo abdominal surgery
- patients who develop SIRS after cardiac surgery with cardiopulmonary bypass
Who cannot join
- patients with a primary diagnosis of acute pancreatitis
- patients with cirrhosis or renal dysfunction
- patients with dyscrasia
- patients with autoimmunity diseases
- patients with severe cardiac and pulmonary diseases
- patients with hematological diseases
- patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Diagnostic and Predictive Value of Circulating microRNAs During Sepsis
MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.
- Conditions
- Sepsis
- Keywords
- sepsis, microRNA
- Medical subject headings
- Sepsis
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 group | Patients who develop sepsis in the ICU | |
| SIRS group | Patients who develop SIRS after cardiac surgery with cardiopulmonary bypass | |
| control group | normal healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative amount of circulating microRNAs
Measured: On the second day of diagnosis of sepsis in ICU
Secondary outcomes (2)
Serum levels of CRP and IL-6
Measured: On the second day of diagnosing sepsis
Apache II score and death
Measured: On the second day of diagnosis of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionJun 2009
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 SepsisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
- Investigators
- Ke-ming Zhu, M.D., Principal investigator, Department of Anesthesiology and Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862290
- Sponsor's protocol ID
- microRNA_sepsis
- Status last verified
- May 2013
- First submitted
- 13 Mar 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang JF, Yu ML, Yu G, Bian JJ, Deng XM, Wan XJ, Zhu KM. Serum miR-146a and miR-223 as potential new biomarkers for sepsis. Biochem Biophys Res Commun. 2010 Mar 26;394(1):184-8. doi: 10.1016/j.bbrc.2010.02.145. Epub 2010 Feb 24.
PubMed 20188071
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Predictive Value of Circulating microRNAs During Sepsis
- ClinicalTrials.gov ID
- NCT00862290
- Acronym / sponsor ID
- microRNA_sepsis
- Conditions
- Sepsis
- Keywords
- sepsis, microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Mar 2009 (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.
MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sepsis group | – | –Patients who develop sepsis in the ICU |
| SIRS group | – | –Patients who develop SIRS after cardiac surgery with cardiopulmonary bypass |
| control group | – | –normal healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who develop sepsis and SIRS
Key inclusion criteria (2 listed)
- patients who develop sepsis and undergo abdominal surgery
- patients who develop SIRS after cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (7 listed)
- patients with a primary diagnosis of acute pancreatitis
- patients with cirrhosis or renal dysfunction
- patients with dyscrasia
- patients with autoimmunity diseases
- patients with severe cardiac and pulmonary diseases
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
Relative amount of circulating microRNAs
Time frame: On the second day of diagnosis of sepsis in ICU
2 secondary outcomes
Serum levels of CRP and IL-6
Time frame: On the second day of diagnosing sepsis
Apache II score and death
Time frame: On the second day of diagnosis of sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Results publication: PubMed 20188071Wang JF, Yu ML, Yu G, Bian JJ, Deng XM, Wan XJ, Zhu KM. Serum miR-146a and miR-223 as potential new biomarkers for sepsis. Biochem Biophys Res Commun. 2010 Mar 26;394(1):184-8. doi: 10.1016/j.bbrc.2010.02.145. Epub 2010 Feb 24.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Ke-ming Zhu, M.D. principal investigator
Department of Anesthesiology and Intensive Care Unit
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, run by Changhai Hospital 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 7 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: finished, as of the sponsor's last update on 3 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative amount of circulating microRNAs (time frame: On the second day of diagnosis of sepsis in ICU). 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 NCT00862290, 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 3 May 2013.