Serum Maresin-1 Predicts the Severity of Severe Acute Pan... | NCT03364920

Studies
Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis

NCT03364920

Sponsor

Weiqin Li

Status

Unknown status

Last Update Posted

Dec 7, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Pancreatitis, Acute

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Jan 1, 2019Estimated

Completion Date

Jan 1, 2020Estimated

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Dec 6, 2017

First Posted Date

Dec 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	The level of serum maresin-1 predicts the severity of severe acute pancreatitis	up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
The incidence of MODS	The level of serum maresin-1 predicts the severity of severe acute pancreatitis	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Severe Acute Pancreatitis
Biliary pancreatitis
7 days of the onset

Exclusion Criteria:

Surgical patients
Serious diseases and infection
Alcoholic pancreatitis
Hypertriglyceridemia pancreatitis
Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI>30

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weiqin Li	Contact	13962531994		luyingying126@sina.cn

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D012769	Shock
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
normal level of serum maresin-1
abnormal level of serum maresin-1