Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641964
• Other study ID #: JSSRMYY-HB-1
• Status: Completed
• Start date: November 2015
• Est. completion date: January 2021

Study information

• Verified date: January 2021
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Necrotizing Pancreatitis
• Acute Respiratory Distress Syndrome
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 ?2 or Fisher exact test.	up to 2 months
Primary	the incidence of ARDS in patients with acute necrotizing pancreatitis		up to 2 months
Secondary	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