Pancreatitis, AcuteNCT03364920
Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis
An observational study of Pancreatitis, Acute, run by Weiqin Li.
Trial summary
This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Acute
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes severe acute pancreatitis between 18ys and 75ys.Patients with disorder of glucolipide metabolism will be excluded. Alcoholic pancreatitis and HTG-AP patients will be also excluded. Patients will be divided into 2 groups according to their level of serum maresin-1.
Who may be able to join
- Clinical diagnosis of Severe Acute Pancreatitis
- Biliary pancreatitis
- 7 days of the onset
Who cannot join
- Surgical patients
- Serious diseases and infection
- Alcoholic pancreatitis
- Hypertriglyceridemia pancreatitis
- Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI>30
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serum Maresin-1 Level Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis Patients
This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.
- Conditions
- Pancreatitis, Acute
- Keywords
- Maresin-1, SAP, IPN, MODS, Mortality
- Medical subject headings
- Pancreatitis, Multiple Organ Failure
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 |
|---|---|---|
| normal level of serum maresin-1 | Not described | |
| abnormal level of serum maresin-1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
The level of serum maresin-1 predicts the severity of severe acute pancreatitis
Measured: up to 28 days
Secondary outcomes (2)
The incidence of MODS
The level of serum maresin-1 predicts the severity of severe acute pancreatitis
Measured: through study completion, an average of 1 year
The incidence of IPN
The level of serum maresin-1 predicts the severity of severe acute pancreatitis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiqin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weiqin Li, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364920
- Sponsor's protocol ID
- SMPSSAP
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Maresin-1 Level Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis Patients
- ClinicalTrials.gov ID
- NCT03364920
- Acronym / sponsor ID
- SMPSSAP
- Conditions
- Pancreatitis, Acute
- Keywords
- Maresin-1, SAP, IPN, MODS, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weiqin LiUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 7 Dec 2017 (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.
This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal level of serum maresin-1 | – | – |
| abnormal level of serum maresin-1 | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes severe acute pancreatitis between 18ys and 75ys.Patients with disorder of glucolipide metabolism will be excluded. Alcoholic pancreatitis and HTG-AP patients will be also excluded. Patients will be divided into 2 groups according to their level of serum maresin-1.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Severe Acute Pancreatitis
- Biliary pancreatitis
- 7 days of the onset
Key exclusion criteria (5 listed)
- Surgical patients
- Serious diseases and infection
- Alcoholic pancreatitis
- Hypertriglyceridemia pancreatitis
- Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI>30
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
mortality
Time frame: up to 28 days
The level of serum maresin-1 predicts the severity of severe acute pancreatitis
2 secondary outcomes
The incidence of MODS
Time frame: through study completion, an average of 1 year
The incidence of IPN
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Acute, run by Weiqin Li.
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 3 inclusion and 5 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Weiqin Li (13962531994, luyingying126@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: up to 28 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 7 Dec 2017.