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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525027
• Other study ID #: EC/12/19/1650
• Status: Completed
• Start date: December 26, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: March 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Hypertension
• Intra-Abdominal Hypertension
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
India	Sir Ganga Ram Hospital	New delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Sir Ganga Ram Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days from inclusion date