Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; 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.

• Study Type: Observational
• Enrollment (Actual): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ARDS group; patients with acute necrotizing pancreatitis complicated by ARDS
non-ARDS group; acute necrotizing pancreatitis patients without ARDS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	up to 2 months

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: Bin He, Master, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 25, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Lung Injury; Infant, Premature, Diseases; Pancreatitis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: JSSRMYY-HB-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes