NCT04525027

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-26
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2020-08-24
• Last updated: 2023-04-03

Locations

1 site across 1 country: India