PROOF: Pancreatitis-associated Risk Of Organ Failure

NCT03075605 | Completed DMC

• 1 other identifier: PRO08010374
• Study Type: observational
• Target: 723
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis.

Conditions

Pancreatitis; Organ Failure, Multiple

Outcome Measures

Primary Outcomes (1)

• Severe Acute Pancreatitis (defined as persistent organ failure)

  To compare the initial immune response in patients who developed mild vs. severe disease. To determine whether functional polymorphisms in inflammation regulating genes predicts a more severe outcome in acute pancreatitis.

  1 year

Study Arms (3)

Subjects with acute pancreatitis

Subjects with acute pancreatitis

Subjects with previous attack

Subjects with previous attack

Controls

Controls

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both males and females, over 1 year of age.

You may qualify if:

• Diagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND Elevated amylase levels by at-least three times the upper limit of normal and/or elevated lipase levels by at-least three times the upper limit of normal (25, 26). Acute pancreatitis must be defined by 2 of the 3 following criteria:
• Serum amylase or lipase elevated greater than 3X upper limit of normal
• epigastric acute pancreatitis pain
• abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis Willingness to participate in the study and sign the informed consent. (Children and subjects who are cognitively impaired for temporary reasons as mentioned in the section 4.7 of this protocol will require a representative to sign the informed consent).
• age criteria as defined above.
• \- Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48 hours or evidence of pancreatic necrosis on computerized tomography.
• Willingness to participate and sign informed consent

You may not qualify if:

• Persons unwilling to sign the informed consent Disorientation secondary to irreversible organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
• Blood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic cancer History of cancer requiring chemotherapy or radiation within the past 1 year History of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical complications
• Persons unwilling to sign the informed consent

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (3)

• Langmead C, Lee PJ, Paragomi P, Greer P, Stello K, Hart PA, Whitcomb DC, Papachristou GI. A Novel 5-Cytokine Panel Outperforms Conventional Predictive Markers of Persistent Organ Failure in Acute Pancreatitis. Clin Transl Gastroenterol. 2021 May 6;12(5):e00351. doi: 10.14309/ctg.0000000000000351.

  PMID: 33955376 DERIVED

• Komara NL, Paragomi P, Greer PJ, Wilson AS, Breze C, Papachristou GI, Whitcomb DC. Severe acute pancreatitis: capillary permeability model linking systemic inflammation to multiorgan failure. Am J Physiol Gastrointest Liver Physiol. 2020 Nov 1;319(5):G573-G583. doi: 10.1152/ajpgi.00285.2020. Epub 2020 Sep 2.

  PMID: 32877220 DERIVED

• Dugum M, Gougol A, Paragomi P, Gao X, Matta B, Yazici C, Tang G, Greer P, Pothoulakis I, O'Keefe SJD, Whitcomb DC, Yadav D, Papachristou GI. Association of Dietary Habits with Severity of Acute Pancreatitis. Curr Dev Nutr. 2018 Oct 8;2(12):nzy075. doi: 10.1093/cdn/nzy075. eCollection 2018 Dec.

  PMID: 30569031 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and DNA and urine samples will be collected and stored without personal identifiers (e.g. using a unique laboratory number or bar code) for future research involving pancreatic diseases to include pancreatitis and pancreatic cancer. Stored biospecimens collected for htis protocol may be shared in a de-identified manner with outside investigators with the approval of the principal investigator.

MeSH Terms

Conditions

Pancreatitis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George Papachristou, MD

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: March 9, 2017
• Study Start: May 20, 2008
• Primary Completion: July 5, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2021

Record last verified: 2021-03