| CTRI Number |
CTRI/2024/12/078818 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to understand the co relation between S. Amylase/CRP/Procalcitonin and severity of abdominal trauma. |
|
Scientific Title of Study
|
A prospective Observational study to assess and correlate the changes in the levels of serum amylase, C-reactive protein and procalcitonin with severity and its significance in cases of abdominal trauma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devendra Pratap Patel |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai Etawah |
| Address |
R.N. 226 Department of General Surgery
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9621181002 |
| Fax |
|
| Email |
devendrapratappatel90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai Etawah |
| Address |
R.N. 226 Department of General Surgery
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7599283875 |
| Fax |
|
| Email |
verma.rajesh4848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai Etawah |
| Address |
R.N. 226 Department of General Surgery
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7599283875 |
| Fax |
|
| Email |
verma.rajesh4848@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai Etawah, Uttar Pradesh, India
Pin code-206130 |
|
|
Primary Sponsor
|
| Name |
UPUMS Saifai Etawah |
| Address |
Saifai Etawah
Pin code 206130 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devendra Pratap Patel |
Uttar Pradesh University of Medical Sciences |
Room no.-226 Department of General Surgery
Etawah
UTTAR PRADESH |
9621181002
devendrapratappatel90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai,Etawah(U.P.)-206130 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients with clinical diagnosis of abdominal trauma |
|
| ExclusionCriteria |
| Details |
Patients with head and spinal injury
Known case of pancreatitis.
Patients below 18 years age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of changes in level of serum amylase, C-reactive protein and procalcitonin with severity in abdominal trauma. |
Serum amylase,C-reactive protein and procalcitonin level in abdominal trauma patients on day-0, day-1, day-3 and day-5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in level of serum amylase, C-reactive protein and procalcitonin at the time of admission will be compared to clinical outcomes in terms of-
-Hospital stay.
-ICU admission rate.
-Operative and non-operative.
-Hospital associated complications.
-Immobilization related complications. |
Serum amylase,C-reactive protein and procalcitonin level in abdominal trauma patients on day-0, day-1, day-3 and day-5. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Caglar Kuas MD et al (2023), conducted a study on the diagnostic value of laboratory tests in detecting solid organ injuries in patients with blunt abdominal trauma on 323 patients in which 118 (36%) were male. There were 283 patients who underwent CT. SOI was detected in 18 (6%) patients. Abnormal alanine aminotransferase, aspartate aminotransferase, amylase and lipase tests were found to be statistically significant in predicting SOI. However, none of the tests were found to have sufficient sensitivity and specificity.Cai-Fung xi (2022) To analyze early changes in white blood cells (WBCs), C-reactive protein (CRP) and procalcitonin (PCT) in children with multiple trauma, before secondary inflammation develops Secondary to multiple trauma, PCT levels increased in more patients, even if their WBC and CRP levels remained unchanged.
Maier, Marcus MD et al (2009) studied on serum Procalcitonin Levels in Patients With Multiple Injuries Including Visceral Trauma from 74 patients with multiple injuries showed that PCT significantly increased during the first two posttraumatic days in patients with severe multiple injuries as compared with patients with identical Injury Severity Score but without abdominal injury assessment of serum PCT seems to be significantly increased after abdominal trauma in severe multiple traumatized patients and may serve as a useful biomarker to support other diagnostic methods including ultrasound and CT scan. Although elevated levels of PCT during the first 2 days after trauma are more likely to be indicative of traumatic impact than of an ongoing status of sepsis, multiple events such as surgery, massive transfusion, and intensive care therapy might influence the PCT concentration. |