Clinical Trial: Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

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 Summary:

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.


Sponsor: Nanjing Medical University

Current Primary Outcome: the incidence of ARDS in patients with acute necrotizing pancreatitis [ Time Frame: up to 2 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the risk factors for ARDS in patients with acute necrotizing pancreatitis [ Time Frame: up to 2 months ]

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.


Original Secondary Outcome: Same as current

Information By: Nanjing Medical University

Dates:
Date Received: December 8, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: March 28, 2017
Last Verified: March 2017