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Clinical Trials/CTRI/2020/09/028076
CTRI/2020/09/028076RecruitingNot Applicable

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

Sir ganga ram hospital1 site in 1 country100 target enrollmentStarted: January 10, 2020Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Mortality

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Mortality

Time Frame: admission till 30 days

Secondary Outcomes

  • SOFA score(APACHE II scores)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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