Clinical trial NCT03253861: PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis
Official title: Risk Factors and Outcomes of Infected Pancreatic Necrosis: Retrospective Cohort of 148 Patients Admitted to the ICU for Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 148
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: Adult patients with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis

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

Detailed description: Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity or ICUs at the Nantes University Hospital, from January 1, 2012, to december 31, 2015. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the development of an infected pancreatic necrosis (highly suspected or proven), 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 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Risk factors of infected pancreatic necrosis
timeFrame: 4 months
Secondary outcomes:
measure: Risk factors of mortality
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Nantes CHU
name: Charlotte Garret, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.