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

NCT ID: NCT04525027

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-26
• Study Completion Date: 2021-10-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

survivors

intra-abdominal pressure in severe acute pancreatitis

Intervention Type: 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

intra-abdominal pressure in severe acute pancreatitis

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

VAMSIDHAR

Trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

vinod singh, MD

Role: STUDY_CHAIR

Sir Ganga Ram Hospital

Locations

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

EC/12/19/1650

Identifier Type: -

Identifier Source: org_study_id