PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis

NCT03253861 | Completed

• 1 other identifier: RC16_0126
• Study Type: observational
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta classification differentiates mild, moderate, and severe acute pancreatitis, and each of these categories correlates with morbidity and mortality. Mortality remains high, between 10% and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30% of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to remove the infected intra-abdominal material, preferably using minimally invasive techniques such as percutaneous and endoscopic drainage, which have been proven beneficial. In several studies biological markers such as procalcitonin and interleukin 8 were effective in predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying risk factors may help to improve standardized strategies for early diagnosis and treatment, and then patients outcome. Our primary objective was to identify risk factors for IPN in patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe the management and outcomes of IPN

Conditions

Acute Necrotizing Pancreatitis; Infection; Pancreatitis

Keywords

Acute necrotizing pancreatitis; Acute pancreatitis; Sepsis/complications; Infection; Organ Dysfunction Scores; Drainage; Catheters; Antibiotics; Multiresistant organism; Pancreatitis/complications; Pancreatitis/diagnosis; Pancreatitis/surgery; Pancreatitis/therapy; Pancreatitis, Acute Necrotizing/complications; Pancreatitis, Acute Necrotizing/surgery; Pancreatitis, Acute Necrotizing/therapy

Outcome Measures

Primary Outcomes (1)

• Risk factors of infected pancreatic necrosis

  Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure

  4 months

Secondary Outcomes (1)

• Risk factors of mortality

  4 months

Study Arms (2)

control patients

patients without an infected pancreatic necrosis

Other: No intervention

Case patients

patients with an infected pancreatic necrosis

Other: No intervention

Interventions

No intervention OTHER

No intervention

Case patients; control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis

You may qualify if:

• Adult patients (age \>18 years) with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis were included.
• Organ failure that resolves within 48 h (transient organ failure) and/or local or systemic complications without persistent organ failure or persistent organ failure (\>48 h)

You may not qualify if:

• mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)

Sponsors & Collaborators

• Nantes University Hospital: lead

Related Publications (1)

• Garret C, Canet E, Corvec S, Boutoille D, Peron M, Archambeaud I, Le Thuaut A, Lascarrou JB, Douane F, Lerhun M, Regenet N, Coron E, Reignier J. Impact of prior antibiotics on infected pancreatic necrosis microbiology in ICU patients: a retrospective cohort study. Ann Intensive Care. 2020 Jun 15;10(1):82. doi: 10.1186/s13613-020-00698-0.

  PMID: 32542577 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Infections; Pancreatitis; Sepsis; Disease

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Garret, MD

  Nantes CHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08