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

NCT04525027 | Completed DMC

• 1 other identifier: EC/12/19/1650
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis; Intra-Abdominal Hypertension

Keywords

severe acute pancreatitis; intra abdominal pressure; mortality; intra abdominal hypertension

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 days from inclusion date

Study Arms (2)

survivors

Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis

non survivors

Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis

Interventions

intra-abdominal pressure in severe acute pancreatitis DIAGNOSTIC_TEST

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; survivors

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Sir Ganga Ram Hospital: collaborator

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

Pancreatitis; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• vinod singh, MD

  Sir Ganga Ram Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 24, 2020
• Study Start: December 26, 2019
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IN (1)