NCT03364920

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 23, 2017

Last Update Submit

December 6, 2017

Conditions

Keywords

Maresin-1SAPIPNMODSMortality

Outcome Measures

Primary Outcomes (1)

  • mortality

    The level of serum maresin-1 predicts the severity of severe acute pancreatitis

    up to 28 days

Secondary Outcomes (2)

  • The incidence of MODS

    through study completion, an average of 1 year

  • The incidence of IPN

    through study completion, an average of 1 year

Study Arms (2)

normal level of serum maresin-1

abnormal level of serum maresin-1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PancreatitisMultiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 23, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

December 7, 2017

Record last verified: 2017-12