Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02641964

Enrollment

350

Registered

2015-12-30

Start date

2015-11-30

Completion date

2021-01-31

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Necrotizing Pancreatitis, Acute Respiratory Distress Syndrome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
the risk factors for ARDS in patients with acute necrotizing pancreatitis	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.

Other

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

Outcome results