CTRI Number |
CTRI/2025/04/085322 [Registered on: 22/04/2025] Trial Registered Prospectively |
Last Modified On: |
22/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Serum D dimer and Procalcitonin Levels at Admission as Predictors of Severity in patients with Acute Pancreatitis |
Scientific Title of Study
|
Serum D-dimer and procalcitonin levels at
admission as predictors of severity in acute pancreatitis: an observational
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 Biswajit Naskar |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences Kalyani |
Address |
Trauma & Emergency Medicine department, AIIMS Kalyani
Nadia WEST BENGAL 741245 India |
Phone |
6290074738 |
Fax |
|
Email |
mynameisjit310789@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Biswajit Naskar |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences Kalyani |
Address |
Trauma & Emergency Medicine Department,AIIMS Kalyani,Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal
Nadia WEST BENGAL 741245 India |
Phone |
6290074738 |
Fax |
|
Email |
mynameisjit310789@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Biswajit Naskar |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences Kalyani |
Address |
Trauma & Emergency Medicine Department, AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal
Nadia WEST BENGAL 741245 India |
Phone |
6290074738 |
Fax |
|
Email |
mynameisjit310789@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245, India |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Kalyani |
Address |
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 |
Type of Sponsor |
Research institution |
|
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 |
Dr Biswajit Naskar |
All India Institute of Medical Sciences Kalyani |
Department of Trauma & Emergency Medicine,
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 Nadia WEST BENGAL |
6290074738
mynameisjit310789@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
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 |
70.00 Year(s) |
Gender |
Both |
Details |
Adult patients (18-70 years) with acute pancreatitis presenting within 24 hrs of symptom onset |
|
ExclusionCriteria |
Details |
1. Pregnancy.
2. Patients presenting more than 24 hours of symptom onset.
3. Chronic pancreatitis
4. Recurrent pancreatitis
5. Age less than 18 years old or over 70 years old
6. Anticoagulant drug use
7. Cancer
8. Thrombotic diseases
9. Liver cirrhosis
10. Patient on immunosuppressive therapy
11. Refusal to give consent |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.To determine if serum D-dimer and procalcitonin levels at the time of admission can predict the severity of acute pancreatitis.
|
Preparation and ethical approval-1-2 months
Data collection- 3 months
Data analysis, reporting and dissemination:1 month
|
|
Secondary Outcome
|
Outcome |
TimePoints |
2.To evaluate whether D-dimer and procalcitonin levels are associated with the development of complications and mortality in patients with acute pancreatitis.
3.To determine the most reliable predictor between D-dimer and procalcitonin for early risk assessment in Acute Pancreatitis patients. |
Preparation and ethical approval-1-2 months
Data collection- 3 months
Data analysis, reporting and dissemination:1 month
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
25/06/2025 |
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="0" Months="3" 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
|
This prospective observational cohort study aims to assess
the predictive value of serum D-dimer and procalcitonin levels at admission in
determining the severity of acute pancreatitis (AP). The study will include
adult patients (18–70 years) presenting within 24 hours of symptom onset. The
Revised Atlanta Classification and Modified Marshall Scoring System will be
used to classify AP severity and assess organ dysfunction. Given the associations
of AP with systemic inflammation, sepsis, and microvascular thrombosis,
procalcitonin and D-dimer levels may serve as early biomarkers for severity
assessment. A total of 62 patients will be recruited, accounting for a 10%
dropout rate. Blood samples will be collected at admission for D-dimer and
procalcitonin measurements. Patients will be monitored for up to 8 days or
until discharge for development of complications, organ failure, and outcomes.
Data will be analysed using SPSS, with ROC curve analysis to evaluate the
predictive accuracy of both biomarkers. Multiple regression will identify
independent predictors of severity and mortality. The study seeks to establish
whether these biomarkers can aid in early risk stratification and guide
clinical decision-making in acute pancreatitis. |