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

Last updated: March 30, 2023
Sponsor: Postgraduate Institute of Medical Education and Research
Overall Status: Completed

Phase

N/A

Condition

Williams Syndrome

Pancreatitis

Stress

Treatment

N/A

Clinical Study ID

NCT04525027
EC/12/19/1650
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 360
Study Start date:
December 26, 2019
Estimated Completion Date:
October 20, 2021

Connect with a study center

  • Sir Ganga Ram Hospital

    New delhi, Delhi 110060
    India

    Site Not Available

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