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CTRI Number  CTRI/2025/03/082700 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the effectiveness of Goal-Directed Fluid Therapy over Standard IV fluid therapy in treatment of Acute Pancreatitis. 
Scientific Title of Study   To Study The effectivenes of Goal-Directed fluid therapy in treatment of Acute Pancreatitis VS Standard IV Fluid Therapy :A RANDOMIZED CONTROLLED TRIAL  
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 Isha Kedia 
Designation  General Surgery Junior Resident 
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD  
Address  MGM Medical College and Hospital Aurangabad
Plot No 16 ,Milan coop HSG society Mayur colony Kothrud Pune -411038
Aurangabad
MAHARASHTRA
431003
India 
Phone  7020925477  
Fax    
Email  ishakedia50521@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Deshmukh  
Designation  Associate Professor  
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD  
Address  MGM Medical College and hospital Aurangabad
Department Of General Surgery MGM Medical College and Hospital Aurangabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  9860986777  
Fax    
Email  vksdeshmukh@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VIKAS DESHMUKH  
Designation  ASSOCIATE PROFESSOR  
Affiliation  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD  
Address  MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD
DEPARTMENT OF GENERAL SURGERY MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD
Aurangabad
MAHARASHTRA
431003
India 
Phone  9860986777  
Fax    
Email  vksdeshmukh@gmail.com  
 
Source of Monetary or Material Support  
MGM Medical College and Hospital Aurangabad, Maharashtra  
 
Primary Sponsor  
Name  MGM Medical College and Hospital Aurangabad Maharashtra  
Address  DEPARTMENT OF SURGERY MGM Medical College and Hospital N6 Cidco Aurangabad 431003 Maharashtra N6,CIDCO , Aurangabad -431003 
Type of Sponsor  Private medical college 
 
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 ISHA KEDIA  Surgery Ward and Surgical ICU MGM Medical College and Hospital  Depart of Surgery MGM Medical College and Hospital Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA 		 7020925477

ishakedia50521@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS   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  Goal directed fluid therapy   Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomized into Group A GDFT(Goal directed fluid therapy) as intervention group and Group B standard fluid therapy as comparator group within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device in intervention group. The intervention group will consist of a protocolized GDFT approach consisting of stroke volume optimization with crystalloid fluid boluses, while the comparator group will receive standard care fluid therapy as advised by the clinical team. The primary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life. Severity score of acute pancreatitis based on clinical ,biochemical and radiological will be calculated at the time of patient evaluation , 4 hr interval , 12 hr interval , 24 hour and 48 hour intervals for both groups. Group A receiving goal directed fluid therapy entails stroke volume optimization along with maintainance fluid administration . At times stroke volume will be calculated of the patient randomly allocated to this group and will be administered 1.5ml per kg per hr of iv crystalloid maintainence fluid therapy. At every 4 hourly visit a bolus of 250cc will be administered over 5 to10 mins if more than 10 percentage sustained rise in sv for about 15 mins is achieved ,patient is fluid responsive and repeated boluses will be administered unless there is no longer sv accelerate. At next 4 hourly visit if the stroke volume has declined by 10 percentage the fluid boluses are repeated until no further increase in the stroke volume . Stroke volume is to be assessed every 4 hourly to check sustained fluid responsiveness. 
Comparator Agent  Standard fluid therapy   Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomized into Group A GDFT(Goal directed fluid therapy) as intervention group and Group B standard fluid therapy as comparator group within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device in intervention group. The intervention group will consist of a protocolized GDFT approach consisting of stroke volume optimization with crystalloid fluid boluses, while the comparator group will receive standard care fluid therapy as advised by the clinical team. The primary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life. Severity score of acute pancreatitis based on clinical ,biochemical and radiological will be calculated at the time of patient evaluation , 4 hr interval , 12 hr interval , 24 hour and 48 hour intervals for both groups. Group B receiving standard care 5 to10ml per kg per hr will be given as maintainence hydration constantly for a period of 48 hours with no fluid boluses and stroke volume measure will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients admitted to MGM medical hospital Aurangabad Maharashtra , with Acute pancreatitis international consensus criteria VII (any 2 of 3)
1)classical pain in abdomen (acute onset of severe epigastric pain ,generally radiating to back)
2) Increase in serum amylase and lipase levels higher than three times the upper limit of normality
3)Signs of Acute pancreatitis on imaging (C T or USG) 
 
ExclusionCriteria 
Details  1)Chronic pancreatitis in which acute exacerbation cannot be confirmed.
2)History of any fluid overload diseases like cardiac failure ,abdominal hypertension ,pleural effusion in the past three months .
3)Unable to provide informed and written consents 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of goal directed fluid therapy in management of acute pancreatitis.  Baseline(0) 4 hours 8 hours 12 hours 16 hours 20 hours 24 hours 28 hours 32hours 36 hours 40hr 44hours and 48hours with follow up post 48hour period until the end of 1st month  
 
Secondary Outcome  
Outcome  TimePoints 
1) To study an assessment of feasibility of trial in India
2)To calculate optimal fluid requirement in management of pancreatitis
3) To study the effectiveness of GDFT in decreasing complications of acute pancreatitis
4) to study cost effectiveness of GDFT by reducing icu stay  		 One month follow up  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   20/03/2025 
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 - NO
Brief Summary   In India, Acute pancreatitis (AP) is on of the most common diseases in middle aged population .Prevalence is 7.9 per 1 lac. For men 8.6 and for women 8 per lac i.
Incidence rate of acute pancreatits is increasing since six decades because of increased alcohol consumption and lifestyle changes in young generation in India .Other causes include gall stones ,idiopathic and drug induced acute pancreatitis ii.Although the majority of clinical presentations of AP is mild in severity ,20-25%develop moderate to severe pancreatitis due to overwhelming SIRS and MOF.iii
There is currently no effective pharmacological treatment available to treat AP. Mainstay of treatment is Fluid and electrolyte balance as a supportive management .Despite the significant importance of this fluid therapy ,there is lack of information on Optimal Fluid Therapy .There are many RCTs in world literature regarding the rate and volume and type of fluid therapy but with conflicting evidence . There are many studies with Moderate fluid therapy ivas well as Aggressive Fluid Therapy but both are ineffective and with many complications as well .Given that the disease severity is variable at presentation ,goal directed fluid therapy (GDFT),has been suggested to guide IV Fluids resuscitation in AP .There are many trials for AP, which are based on biochemical measures but have failed to show reduction in treating SIRS and MOF. Randomized control Trials based on hemodynamic measures such as stroke volume and cardiac output have shown to be more effective in decreasing morbidity and mortality in AP. The British Medical Journal has published a study in 2019, Ward – based Goal Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial ,where Optimal Fluid Volume is administered in first 48 hours (Golden period for management ) by measuring CO and SV on non invasive cardiac monitors .Results of this study are promising .It has concluded that the study is feasible ,safe ,acceptable by patients and clinicians ,and have less complications of AP, with fewer ICU admissions ,hence less expensive with decreased morbidity and mortality . 
 
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