PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis

NCT ID: NCT03253861

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-06-01

Brief Summary

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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

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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.

Conditions

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Acute Necrotizing Pancreatitis Infection Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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control patients

patients without an infected pancreatic necrosis

No intervention

Intervention Type OTHER

No intervention

Case patients

patients with an infected pancreatic necrosis

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Garret, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes CHU

References

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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.

Reference Type DERIVED
PMID: 32542577 (View on PubMed)

Other Identifiers

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RC16_0126

Identifier Type: -

Identifier Source: org_study_id

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