Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04525027
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2020-08-18
Brief Title:
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe Acute Pancreatitis SAP is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality Increased Intra-abdominal PressureIAP 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 krons 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 clinicians 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None