Clinical trial NCT04525027: Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis
Official title: Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Intra-Abdominal Hypertension
Keywords: severe acute pancreatitis
intra abdominal pressure
mortality
intra abdominal hypertension
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Sir Ganga Ram Hospital
First posted: 2020-08-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of acute severe pancreatitis admitted to ICU within 72 hours of symptom onset

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.


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

Primary outcomes:
measure: Mortality
timeFrame: 30 days from inclusion date
Secondary outcomes:
Other outcomes:
Locations:
city: New delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
Study officials:
affiliation: Sir Ganga Ram Hospital
name: vinod singh, MD
role: STUDY_CHAIR
References: