| CTRI Number |
CTRI/2024/08/072112 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
low calcium in trauma patients |
|
Scientific Title of Study
|
Prevalence of ionized hypocalcaemia in trauma patients and its role in predicting mortality at level I trauma centre- A prospective 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 |
MOHD TAHIR |
| Designation |
Junior resident |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of trauma surgery, 8th floor Shatabdi phase ll, King George’s medical university Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9161732604 |
| Fax |
|
| Email |
tahirsharif91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANITA SINGH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of trauma surgery, 8th floor Shatabdi phase ll, King George’s medical university Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
941517780 |
| Fax |
|
| Email |
dranitasinghsurgery@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHD TAHIR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of trauma surgery, 8th floor Shatabdi phase ll, King George’s medical university Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9161732604 |
| Fax |
|
| Email |
tahirsharif91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of trauma surgery, 8th floor Shatabdi phase ll, King George’s medical university Lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
KING GEORGES MEDICAL UNIVERSITY, Lucknow, UP, India 226003 |
| 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 MOHD TAHIR |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW, UTTAR PRADESH, INDIA |
TRAUMA CENTRE FIRST FLOOR TRAUMA SURGERY WARD (TSW) KGMU,LUCKNOW
Lucknow
UTTAR PRADESH |
9161732604
tahirsharif91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George’s Medical University U.P., Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T148||Other injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All aged and of both sex in first 48 hour of arrival.
Hemodynamically stable and unstable patient
Patients giving written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant patients
Patient k/c/o CKD, parathyroid disease, metabolic bone disease,sepsis induced hypocalcemia and severe traumatic brain injury
Bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of hypocalcemia in trauma patients
To predict the mortality in hypocalcemic patients
|
Day 0, day 2, day 5 and time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To established the correlation between ionised hypocalcemia and outcome
To triage the patients on presence and absence of hypocalcemia
|
Day 0, day 2, day 5 and time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
19/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Trauma is a leading cause of morbidity and mortality, particularly in younger populations. Hypocalcemia, common in trauma patients, exacerbates hemorrhagic shock and is associated with worse outcomes. Calcium is essential for various physiological processes, including coagulation and myocardial function. Trauma and transfusions often lead to hypocalcemia, which worsens due to the chelation effect of citrate in blood products. This study aims to assess the prevalence of ionized hypocalcemia in trauma patients and its role in predicting mortality at a level I trauma center. It will involve a prospective observational study with a sample size of 207 patients, analyzing the correlation between hypocalcemia and patient outcomes. Data will be collected on ionized calcium levels at multiple points and analyzed using statistical methods. Prior research has shown a strong link between hypocalcemia and increased mortality, highlighting the need for further study and optimized resuscitation protocols. |