| CTRI Number |
CTRI/2025/05/087283 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
For patients with severe acute pancreatitis, is early feeding safer and more effective than waiting? |
|
Scientific Title of Study
|
To assess the effect of early enteral feeding VS delayed enteral Feeding in mild and moderate acute pancreatitis patients in a tertiary care hospital in puducherry |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayasti.P |
| Designation |
Post graduate |
| Affiliation |
Indira Gandhi medical College and research institute , Kathirkamam, puducherry |
| Address |
Room no :3,
Department of General Medicine Indira Gandhi medical College and research institute , kathirkamam , puducherry.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9361239609 |
| Fax |
|
| Email |
drjayasti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Balasubramanian |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi medical College and research institute , Kathirkamam, puducherry |
| Address |
Room no :3 Department of General Medicine , Indira Gandhi Medical college and research institute , kathirkamam , puducherry Pincode:605010 India
Pondicherry
PONDICHERRY
PONDICHERRY
605010
|
| Phone |
9443436603 |
| Fax |
|
| Email |
drbala71@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Balasubramanian |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi medical College and research institute , Kathirkamam, puducherry |
| Address |
Room no :3 Department of General Medicine Indira Gandhi Medical college and research institute , kathirkamam , puducherry Pincode:605010 India
Pondicherry
PONDICHERRY
PONDICHERRY
605010
|
| Phone |
9443436603 |
| Fax |
|
| Email |
drbala71@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi medical College and research Institute, kathirkamam. Puducherry
Pin code:605010
India |
|
|
Primary Sponsor
|
| Name |
Jayastip |
| Address |
Indira Gandhi medical college and research institute, kathirkamam, puducherry .
Pincode :605010 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrJayasti |
Indira Gandhi Medical college and Research Institute. |
Room no :3
Department of General Medicine Indira Gandhi Medical college and research institute , kathirkamam , puducherry
Pincode:605010
India
Pondicherry
PONDICHERRY |
9361239609
drjayasti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutes ethical 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 |
| Intervention |
Early vs delayed enteral feeding in mild and moderate acute pancreatitis |
A patient will be given either early enteral nutrition with in 24 hours of admission or delayed enteral nutrition after 48 hrs of admission .
|
| Intervention |
Early vs delayed enteral feeding in Mild and Moderate Acute pancreatitis. |
A patient will be given delayed enteral nutrition after48 hrs of admission in Mild and Moderate pancreatitis. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 20 years including both the sexes who are diagnosed as mild and moderate pancreatitis based on Balthazar CT severity index ( score less than 7) at the time of admission |
|
| ExclusionCriteria |
| Details |
Age less than 20 years
chronic pancreatitis
severe acute pancreatitis based on Balthazar CT severity index ( score more than 7)
pancreatic cancer
shock at the time of presentation (systolic BP less than 90 mm hg)
Patients with co-morbidities like COPD, Renal impairment
Pregnant women
patient with known history of allergy to iodinated contrast agents
All patients who will not give consent for study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of early vs delayed enteral feeding in mild and moderate acute pancreatitis |
Day 1 and day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the BUN/albumin ratio as severity predictors in acute pancreatitis. |
Day 4 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2025 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study is plan to conducted in IGMC&RI in the department of General medicine among mild and moderate acute pancreatitis based on Balthazar CT severity index the patients were divided by simple randomization into 2 groups as A & B. Group A receives early enteral feeding ( within 24 hours) and Group B receives delayed enteral feeding ( after 48 hours ). SOFA and BUN/Albumin ratio will be measured in both the groups at the time of admission, Enteral nutrition: 25- 30 Kcal / kg/ day , 200 – 300 ml, 5-6 times /day, Intermittent bolus Feeds were commenced at full strength and a rate of 30 ml/h increasing to 100 ml/h over 24–48 h. SOFA score and BUN/Albumin ratio will be measured in both the groups after 4 days of admission . Assess the effect of early vs delayed enteral nutrition in view of reducing the systemic/local complication, organ failure and length of hospital stay. |