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Completed

NCT Number: NCT02641964

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.

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Key information

Conditions

Acute Necrotizing Pancreatitis Acute Respiratory Distress Syndrome Digestive System Diseases Lung Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the incidence of ARDS in patients with acute necrotizing pancreatitis

    Time frame: up to 2 months

Secondary outcomes

  1. 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.

Other outcomes

  1. the effect of ARDS on mortality in patients with severe acute pancreatitis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2015
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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