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CTRI Number  CTRI/2024/02/062750 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Steps to reduce intra-abdominal pressure]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two different treatment modalities to reduce the increased abdominal pressure that happens in patients with acute pancreatitis  
Scientific Title of Study   Evaluation of impact of intra- abdominal hypertension on outcome in patients of acute pancreatitis and comparative study between step up approach and simultaneous approach for management of reduction of IAP in patients of acute pancreatitis with IAH: A randomised control study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayanta Samanta 
Designation  Associate Professor 
Affiliation  PGIMER Chandigarh India  
Address  Room no 20, Department of Gastroenterology, Level I, Block F, Nehru Hospital. Postgraduate Institute of Medical Education and Research, Chandigarh Sector - 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayanta Samanta 
Designation  Associate Professor 
Affiliation  PGIMER Chandigarh India  
Address  Room no 20, Department of Gastroenterology, Level I, Block F, Nehru Hospital. Postgraduate Institute of Medical Education and Research, Chandigarh Sector - 12 Chandigarh


CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Purnima Patial 
Designation  Senior Resident  
Affiliation  PGIMER chandigarh India  
Address  Gastroenterology Office, Department of Gastroenterology, Level I, Block F, Nehru Hospital Postgraduate Institute of Medical education and Research, Chandigarh Sector - 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9459764755  
Fax    
Email  purnimapatial619@gmail.com  
 
Source of Monetary or Material Support  
Department of Gastroenterology, PGIMER, Chandigarh 
 
Primary Sponsor  
Name  Dr. Jayanta samanta 
Address  Room 20, Ground Floor, Block F, Nehru Hospital PGIMER, Chandigarh Sector -12 Chandigarh - 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayanta Samanta  PGIMER, Chandigarh  Department of Gastroenterology,PGIMER, Chandigarh Sector-12 Chandigarh
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Simultaneous Strategy   In simultaneous approach, all measures will be taken upfront within 24 hours of randomization to decrease IAP, viz., Ryle’s tube and flatus tube insertion, neostigmine for ileus, and PCD for ascites/drainable collection. IAP will be measured every 12 hourly and percentage decrease in IAP will be noticed. If there is less than 25% decrease in IAP after 24 hours, further intervention will be in the form of placement of PCD in any other residual collection, not placed in the previous step, and deemed contributory to IAH or plain PCD will be inserted in abdomen under ultrasound guidance if not placed earlier, to decrease raised intra-abdominal pressure. All patients enrolled will be followed daily till discharge of patient or death. The steps of the protocol will be stopped once normalisation of the IAP is achieved. At any stage, if the patient develops ACS, surgical intervention would be sought and adequate measures initiated.  
Comparator Agent  Step-up Strategy  In this group, IAP will be measured at baseline after randomization and then 12 hourly intervals. Our previously published data has shown that less than 30% reduction in IAP after 24 hours of intervention was a significant mortality predictor. Hence, after each step of intervention, patients will be assessed for reduction of IAP at 24 hrs. If there was less than 25% reduction in IAP after 24 hours, the patients will be subjected to the next intervention for reduction of IAP. In the step-up approach, the measures will be from least invasive to more invasive techniques. In step 1 Ryles tube will be inserted and IAP will be measured every 12 hourly. If IAP reduces by more than 25% after 24 hrs. patient will be managed as per treatment protocol of institution. If IAP reduction is less than 25% , we will move onto next step. In step 2, flatus tube will be inserted and IAP will be measured 12 hourly. If IAP reduction is less than 25% then next step will be taken. In step 3, injection neostigmine 1 mg intramuscularly will be given ( two doses 12 hours apart) if ileus is present, and IAP will be measured after every 12 hours. If IAP decreases by 25% after 24 hours, patient will be managed as per treatment protocol of institution. If IAP increases or decrease is less than 25% , we will onto step 4 In step 4, PCD will be inserted in first in ascites and in absence of that in any drainable collection. If IAP reduction is less than 25% after 24 hours of PCD insertion, then patient will be managed as per institution protocol and IAP will be measured every 12 hourly.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient’s age ≥ 18 years
2. Informed consent for participation in the study
3. All patients of acute pancreatitis presenting within 14 days of pain onset.
4. Presence of intra-abdominal hypertension as per the definition 
 
ExclusionCriteria 
Details  History of arrhythmia
Bronchial asthma
pregnancy
history of laparotomy
prior endoscopic/radiological/surgical intervention
lack of informed consent  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The percentage difference in the reduction of IAP at 72 hrs between step up approach and simultaneous approach for management of IAH
2. Composite outcome parameter of mortality, surgery, need for ventilator and development of new onset multiple organ failure 		 1. At the end of 72 hrs of intervention
2. At the end of the index hospital admission  
 
Secondary Outcome  
Outcome  TimePoints 
a. Resolution of organ failure
b. Duration of organ failure
c. Development of infected pancreatic necrosis or other infective complications
d. Length of hospital stay and ICU stay
e. Need for organ support in the form of ventilator requirement, renal replacemnet therapy
f. Need for surgery
g. Mortality 		 At the end of the index hospital admission  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2 
Date of First Enrollment (India)   01/03/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dj_samanta@yahoo.co.in].

  6. For how long will this data be available start date provided 15-06-2027 and end date provided 15-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Patients with SAP tend to have elevated intra- abdominal pressure (IAP), which can lead to intra- abdominal hypertension (IAH)  and subsequently to abdominal compartment syndrome (ACS). About 11–40 % of SAP patients suffer from complications of ACS. Incidence of IAH in patients of SAP varies from 60- 80%. The degree of IAP in patients with SAP seems to correlate with the degree of organ dysfunction, the severity of the disease, the length of the stay at hospital and mortality.  We have established in our previous studies that IAH is a poor outcome predictor and that reduction of IAP improves survival. Moreover, we have also established that failure of early reduction of IAP can lead to deleterious outcomes. Thus early detection and rapid treatment of IAH is key to improve outcome in AP patients with IAH. Interestingly, the key factors contributing to the development of IAH in AP include paralytic ileus leading to bowel distension, ascites, peripancreatic fluid collections, mesenteric inflammation, and abdominal pain in various combinations. The current strategy involves step wise intervention to address these factors in the form of minimally invasive techniques such as Ryle’s tube insertion and flatus tube insertion to start with and insertion of percutaneous catheter drain at a later phase in cases of non-improvement. However, it is imperative to note that time is key to obtain highest benefit from interventions to reduce IAP, as pointed above. Whether all the interventions applied simultaneously would benefit earlier or have better synergistic effects in reducing the IAP has not been studied.  Hence we planned this study to monitor IAP in patients of acute pancreatitis and to compare the two strategies of conventional step-up approach and a simultaneous approach for management of IAH in patients of acute pancreatitis in a randomised control trial. 
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