Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis

Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis: A Prospective Observational Study

Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. Abdominal Compartment Syndrome (ACS) is defined as IAP greater than 20 mm of Hg and is considered an abdominal catastrophe. Intra-abdominal Hypertension (IAH, Intra-abdominal pressure > 12mm of Hg), may contribute to early organ dysfunction, ACS and eventually hemodynamic collapse if left untreated. This signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop IAH /ACS and predicting mortality associated with the condition. Measurement of IAP will be done indirectly by measuring intravesicular pressure using modified kron's method. IAP will be measured at the time of admission into Intensive Care Unit (ICU) and every day thereafter during the initial five days of ICU admission. Any reading of IAP ≥12 mm of Hg shall be considered as IAH. SOFA and APACHE II score will be noted on the day of admission in the ICU. Any interventions, surgical or non surgical as per clinician's decision will be recorded. The patients will be followed up until discharge or mortality until 30 days. The proposed study aims to assess the predictive ability of IAP during the first 5 days of ICU admission for predicting mortality in patients with SAP. Prediction accuracy will also be compared with SOFA and APACHE II scores.

Study Overview

• Status: Completed
• Conditions: Intra-Abdominal Hypertension; Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: intra-abdominal pressure in severe acute pancreatitis

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

• Study Contact: Name: vamsidhar amburu, MD; Phone Number: +919814866818; Email: rahdismav_a@yahoo.com

Study Locations

• India
  • Delhi
    • New delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients of acute severe pancreatitis admitted to ICU within 72 hours of symptom onset

Description

Inclusion Criteria:

>Patients with severe acute pancreatitis in the age group of 18-65 years admitted to ICU within 72 hours of onset of symptoms

Exclusion Criteria:

• Previous history of any abdominal or pelvic surgery
• Known case of bladder tumor or bladder abnormality.
• Difficulty in urinary catheterization
• Use of neuromuscular blockade
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
survivors	Diagnostic test: intra-abdominal pressure in severe acute pancreatitis; daily intra abdominal pressures in patients admitted to ICU will be measured and noted for intial 5 days and followed up until end outcome
non survivors	Diagnostic test: intra-abdominal pressure in severe acute pancreatitis; daily intra abdominal pressures in patients admitted to ICU will be measured and noted for intial 5 days and followed up until end outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days from inclusion date

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborators: Sir Ganga Ram Hospital
• Investigators: Study Chair: vinod singh, MD, Sir Ganga Ram Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: mortality; severe acute pancreatitis; intra abdominal pressure; intra abdominal hypertension
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Pancreatic Diseases; Compartment Syndromes; Hypertension; Pancreatitis; Intra-Abdominal Hypertension
• Other Study ID Numbers: EC/12/19/1650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No