| CTRI Number |
CTRI/2025/07/090110 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prognostic ability of Hematocrit to Albumin ratio in Acute Pancreatitis Patient |
|
Scientific Title of Study
|
A Prospective Observational study on Prognostic ability of Hematocrit to Albumin ratio in Acute Pancreatitis Patient |
| 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 Arjun MH |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9962427778 |
| Fax |
|
| Email |
arjun1.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SS PRASAD |
| Designation |
Associate Dean Professor and Head of Department of General Surgery |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8073680789 |
| Fax |
|
| Email |
Prasad.ss@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun MH |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
KARNATAKA
576104
India |
| Phone |
9962427778 |
| Fax |
|
| Email |
arjun1.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrArjun MH |
| Address |
Department of General Surgery,3rd floor , smt.Sharadav Madhav Pai OPD, Kasturba Hospital,Manipal-576104,Udupi District,Karnataka,INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Arjun MH |
Kasturba Medical College and Hospital |
3rd floor, Department of General Surgery, smt.Sharadav Madhav Pai OPD, Kasturba Hospital,Manipal-576104,Udupi District, Karnataka, INDIA
Udupi
KARNATAKA |
9962427778
arjun1.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K85||Acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with acute pancreatitis based on the 2012 revised Atlanta Classification
Patient who provide informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with acute pancreatitis with significant unrelated complication (e.g. Nephrotic syndrome, CLD)
Patient with severe life threatening conditions (e.g.CKD STAGE 5,Malignancy)
Patient diagnosed with chronic pancreatitis or a history of recurrent pancreatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the relationship between Hematocrit to albumin ratio and severity of acute pancreatitis |
1 years and 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Asses hematocrit to albumin ratio are associated with clinical outcomes, including complications and mortality rate. |
1 years 7 months |
| Analyze the incidence of complications(e.g., necrosis, infection, organ failure)in relation to the hematocrit to albumin ratio and insight their roles as potential biomarkers for complications. |
1 year 7 months |
|
|
Target Sample Size
|
Total Sample Size="173"
Sample Size from India="173"
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)
|
01/08/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A Prospective Observational Study on Evaluating the Significance of the Hematocrit-to-Albumin Ratio in Predicting the Severity, Complications, and Prognosis of Acute Pancreatitis. The purpose of this study is to provide and simplify scoring systems for the prognosis of acute pancreatitis. The study is done between August 2025 to March 2027. Informed consent will be obtained from all willing participants, with minimal risk involved. For patients eligible under the inclusion criteria, the hematocrit-to-albumin values will be obtained. These investigations are routine and commonly investigated parameters. The hematocrit-to-albumin ratio shall be calculated and divided into two groups of high risk and low risk and shall be followed up to discharge. Sensitivity and specificity shall be calculated using the area under the curve, which helps to determine the relationship between the hematocrit-to-albumin ratio and the severity of acute pancreatitis |