| CTRI Number |
CTRI/2021/01/030806 [Registered on: 28/01/2021] Trial Registered Prospectively |
| Last Modified On: |
14/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of CRP/albumin ratio in predicting severity of acute pancreatitis |
|
Scientific Title of Study
|
Role of CRP/albumin ratio in acute pancreatitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Jayanth |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of general surgery, 3rd floor, OPD block, Kasturba hospital, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9492177086 |
| Fax |
|
| Email |
jayanth.r2@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S S Prasad |
| Designation |
Professor |
| Affiliation |
Department of general surgery, Kasturba medical college, Manipal |
| Address |
Department of general surgery, 3rd floor, OPD block, Kasturba hospital, Madhav nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105468373 |
| Fax |
|
| Email |
prasad.ss@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshama S Hegde |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of general surgery, 3rd floor, OPD block, Kasturba hospital, madhav nagar, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9538075336 |
| Fax |
|
| Email |
kshama.hegde@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college Manipal |
| Address |
Kasturba medical college, madhav nagar, Manipal, Udupi(dt), 576104 |
| 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 |
| Dr R Jayanth |
Kasturba hospital |
Department of General surgery, 3rd floor, OPD block, Kasturba hospital, madhav nagar, manipal, udupi(dt), 576104
Udupi
KARNATAKA |
9492177086
jayanth.r2@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: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with acute pancreatitis. |
|
| ExclusionCriteria |
| Details |
1) Pregnancy
2) Patients with chronic liver disease
3) Recurrent/chronic pancreatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reliability of CRP/albumin ratio in predicting the severity, morbidity and mortality in acute pancreatitis |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of crp/albumin ratio in predicting prognosis of acute pancreatitis compared to routinely used other investigations |
10 days |
|
|
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)
|
31/01/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Deidentified data will be shared if a written request is made
- For how long will this data be available start date provided 20-01-2023 and end date provided 20-01-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
It is a prospective observational study. Patients who will be diagnosed with acute pancreatitis and satisfying the criteria will be included. Standard data will be collected during patients admissions as a part of routine clinical practice. Data will be extracted from this data base. CRP/albumin ratio will be calculated and compared with other routine investigations that are routinely used in cases of pancreatitis (isolated CRP, hematocrit, Glasgow imrie score, BMI, CT severity) in assessing the severity and prognosis of the disease. |