NCT02641964

Brief Summary

Try to collect about 350 cases of acute necrotizing pancreatitis at the First Affiliated Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military Command. Then the investigators studied the incidence and the risk factors of ARDS in patients with acute necrotizing pancreatitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

5.2 years

First QC Date

December 8, 2015

Last Update Submit

January 22, 2021

Conditions

Acute Necrotizing PancreatitisAcute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • the incidence of ARDS in patients with acute necrotizing pancreatitis

    up to 2 months

Secondary Outcomes (1)

  • the risk factors for ARDS in patients with acute necrotizing pancreatitis

    up to 2 months

Other Outcomes (1)

  • the effect of ARDS on mortality in patients with severe acute pancreatitis

    up to 2 months

Study Arms (2)

ARDS group

patients with acute necrotizing pancreatitis complicated by ARDS

non-ARDS group

acute necrotizing pancreatitis patients without ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the investigators reviewed all patients with a diagnosis of pancreatitis admitted to surgical wards or ICUs at the First Affiliated Hospital with Nanjing Medical University and Nanjing General Hospital of Nanjing Military Command from January 1, 2009, to October 31, 2015.Adult patients (age \>18 years) with acute necrotizing pancreatitis were enrolled.

You may qualify if:

  • Adult patients (age \>18 years) with acute necrotizing pancreatitis

You may not qualify if:

  • lack of radiologic evidence to diagnose acute necrotizing pancreatitis,
  • presence of ARDS before admission to hospitals,
  • unable to partner treatment and leaving hospitals,
  • transferring to the investigators' hospitals after treatment,
  • missing other necessary data,
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis, Acute NecrotizingRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Bin He, Master

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency department physician

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 30, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share