Risk Factors for ARDS in Patients With Acute Necrotizing... | NCT02641964

Studies
Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

NCT02641964

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Jan 25, 2021Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Acute Necrotizing Pancreatitis
Acute Respiratory Distress Syndrome

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Jan 2021Actual

Completion Date

Jan 2021Actual

First Submitted Date

Dec 8, 2015

First Submission Date that Met QC Criteria

Dec 25, 2015

First Posted Date

Dec 30, 2015Estimated

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

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

Using electronic patient data monitoring systems, 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. Inclusion criteria were adult patients (age >18 years) with acute necrotizing pancreatitis. Exclusion criteria were as follows : 1) lack of radiologic evidence to diagnose acute necrotizing pancreatitis, 2) presence of ARDS before admission to hospitals, 3) unable to partner treatment and leaving hospitals, 4) transferring to the investigators' hospitals after treatment, 5) missing other necessary data, and 6) pregnancy.

For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to ARDS or non-ARDS, and the differences of these characteristics between two groups were evaluated. Potential risk factors were collected and studied by using multiple logistic regression analysis.

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

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARDS group		patients with acute necrotizing pancreatitis complicated by ARDS
non-ARDS group		acute necrotizing pancreatitis patients without ARDS

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of ARDS in patients with acute necrotizing pancreatitis		up to 2 months

Secondary Outcomes

Measure	Description	Time Frame
the risk factors for ARDS in patients with acute necrotizing pancreatitis	Potential risk factors included smoking, alcohol abuse, diabetes mellitus, abdominal surgery, shock, hypoalbuminaemia, hypertriglyceridemia and hypercholesterolemia.Univariate analyses examined potential risk factors on outcome (ARDS or non-ARDS). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk for the onset of ARDS.

Other Outcomes

Measure	Description	Time Frame
the effect of ARDS on mortality in patients with severe acute pancreatitis	The mortality were compared between ARDS and non-ARDS patients with severe acute pancreatitis. The differences were evaluated by χ2 or Fisher exact test.	up to 2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bin He, Master	Nanjing Medical University	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019283	Pancreatitis, Acute Necrotizing
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases

Browse Leaves

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Browse Branches

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