| CTRI Number |
CTRI/2020/09/028076 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
21/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Does raised intrabdominal pressure increase mortality in acute pancreatitis |
|
Scientific Title of Study
|
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With
Severe Acute Pancreatitis: A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vamsidhar amburu |
| Designation |
DNB Trainee |
| Affiliation |
sir ganga ram hospital |
| Address |
Institute of critical care medicine, 4th floor, ssrb
Central
DELHI
110060
India |
| Phone |
9814866818 |
| Fax |
|
| Email |
rahdismav_a@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod k singh |
| Designation |
Consultant |
| Affiliation |
sir ganga ram hospital |
| Address |
Consultant room, institute of critical care medicine
Central
DELHI
110060
India |
| Phone |
|
| Fax |
|
| Email |
vinodksingh66@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
vamsidhar amburu |
| Designation |
DNB Trainee |
| Affiliation |
sir ganga ram hospital |
| Address |
Institute of critical care medicine, ssrb 4th floor
Central
DELHI
110060
India |
| Phone |
9814866818 |
| Fax |
|
| Email |
rahdismav_a@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir ganga ram hospital |
| Address |
rajinder nagar, delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinod k singh |
sir ganga ram hospital |
institute of critical care medicine/4th floor/ main ICU/ SSRB block
Central
DELHI |
9810301011
vinodksingh66@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with severe acute pancreatitis in the age group of 18-65 years
Patients with severe acute pancreatitis admitted to ICU within 72 hours of
onset of symptoms
|
|
| ExclusionCriteria |
| Details |
1. Previous history of any abdominal or pelvic surgery 2. Known
case of bladder tumour or bladder abnormality. 3. Difficulty in urinary
catheterization 4. Use of neuromuscular blockade 5. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
admission till 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SOFA score
APACHE II scores |
admission till end outcome |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |