Significance of Collections Around Colon in Patients With Acute Necrotizing Pancreatitis

NCT03411629 | Completed DMC

• 1 other identifier: 2017-235-IP-EXP
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis is an inflammatory process which causes a local and systemic inflammatory response syndrome (SIRS). Although the majority of patients have a mild disease course, around 20% will develop moderate or severe pancreatitis, with necrosis of the (peri) pancreatic tissue and/or multiple-organ failure. Previous studies have correlated colonic involvement as a prognostic marker in acute pancreatitis. It is well known that translocation of the colonic flora may significantly influence the clinical course of patients with acute pancreatitis. The correlation between collection(s) around colon in CT finding and clinical outcomes has not been studied in necrotizing pancreatitis. In current study, the investigators will do a prospective observational study correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis.

Conditions

Acute Necrotizing Pancreatitis

Keywords

Necrotizing Pancreatitis; Critically ill; Mortality

Outcome Measures

Primary Outcomes (1)

• Correlating collection(s) around the colon and clinical course of patients in acute necrotizing pancreatitis.

  To study CT finding of collection(s) around colon in patients with acute necrotizing pancreatitis and its association with clinical course i.e. intra-abdominal infection, need of drain/surgery and survival at ICU discharge..

  Up to 6 weeks of the acute pancreatitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis.

You may qualify if:

• All adult (≥18 years) ICU patients who had acute necrotizing pancreatitis will be considered.

You may not qualify if:

• Age \<18 years
• Pregnancy

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Critical Illness

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 26, 2018
• Study Start: January 12, 2018
• Primary Completion: April 11, 2019
• Study Completion: May 18, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

IN (1)