| CTRI Number |
CTRI/2023/02/049542 [Registered on: 08/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using the value of red blood cell distribution and dividing it by blood level of calcium in people with recent pancreas disease to obtain a value to see how fast the disease worsens and causes death. |
|
Scientific Title of Study
|
Red Cell Distribution Width to Serum Calcium ratio as a predictor of severity and mortality of 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 |
Varsha Janakiramanan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education (MAHE) |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9108768709 |
| Fax |
|
| Email |
varshajr@rocketmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Weena Stanley |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education (MAHE) |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844111974 |
| Fax |
|
| Email |
weena.stanley@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Janakiramanan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal, Manipal Academy of Higher Education (MAHE) |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9108768709 |
| Fax |
|
| Email |
varshajr@rocketmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
Varsha Janakiramanan |
| Address |
Department Of General Medicine, KMC Manipal, Karnataka |
| 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 |
| Varsha Janakiramanan |
Kasturba Hospital, Manipal |
Department Of General Medicine,Room 6,
Kasturba Medical College, Manipal, Madhav Nagar, Udupi,Karnataka
Udupi
KARNATAKA |
9108768709
varshajr@rocketmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KH and KMC 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. > 18 years old
2.Diagnosed as acute pancreatitis based on:
1.Clinical presentation with acute persistent abdominal pain
2.Serum amylase exceeding 3 times the upper limit of normal (100 IU/L)
3.Characteristic findings on abdominal ultrasonography and/or computed
tomography
At least 2/3 |
|
| ExclusionCriteria |
| Details |
1. Acute coronary syndrome
2. Congestive cardiac failure
3. Acute pulmonary embolism
4. Cerebrovascular accident
5. Malignancy
6. Chronic kidney disease
7. Chronic liver disease
8. Recent transfusion history
9. Pregnancy
10. Trauma
11. Anemia (Hb <10g/dl) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict the severity and mortality in patients with acute pancreatitis using RDW to serum
calcium ratio. |
February 2024 to July 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To prognosticate the severity and mortality of acute pancreatitis with the BISAP score (Blood urea nitrogen, Impaired
mental status, SIRS, Age, Pleural Effusion), Neutrophil to Lymphocyte (NLR) ratio, Platelet to Lymphocyte Ratio (PLR) ratio. |
February 2024 to July 2024 |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
11/02/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute pancreatitis has a significant incidence rate and the prognosis of this condition depends on early identification of severity for initiation of prompt treatment. Hence, this study uses the ratio of Red cell Distribution width to Serum Calcium, to prognosticate the progression of acute pancreatitis based on BISAP scores and NLR, PLR ratios to aid in the same.
The trend of the ratio would be looked at to act as a predictor of severity and mortality of acute pancreatitis. |