Clinical trial NCT02641964: Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis
Official title: Risk Factors for ARDS in Patients With Acute Necrotizing Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Necrotizing Pancreatitis
Acute Respiratory Distress Syndrome
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: the incidence of ARDS in patients with acute necrotizing pancreatitis
timeFrame: up to 2 months
Secondary outcomes:
measure: the risk factors for ARDS in patients with acute necrotizing pancreatitis
timeFrame: up to 2 months
Other outcomes:
measure: the effect of ARDS on mortality in patients with severe acute pancreatitis
timeFrame: up to 2 months
Locations:
Study officials:
affiliation: Nanjing Medical University
name: Bin He, Master
role: STUDY_DIRECTOR
References: