| CTRI Number |
CTRI/2025/10/096472 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Increase in lactate and Hypocalcemia as predictors of mortality in polytrauma patients |
|
Scientific Title of Study
|
Hyperlactemia and Hypocalcemia as predictors of mortality in polytrauma patients 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 |
Reeti Sharma |
| Designation |
Junior Resident Doctor |
| Affiliation |
King George Medical University Lucknow |
| Address |
Room no 215 RALC Girls Hostel Daliganj Lucknow
Room no 215 RALC Girls Hostel Daliganj Lucknow
Gautam Buddha Nagar
UTTAR PRADESH
226018
India |
| Phone |
7351325457 |
| Fax |
|
| Email |
reetisharma777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zia Arshad |
| Designation |
Professor |
| Affiliation |
King George Medical University Lucknow |
| Address |
Department of Anaesthesia
KGMU Lucknow
Department of Anaesthesia
KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415722226 |
| Fax |
|
| Email |
ziaarshad13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reeti Sharma |
| Designation |
Junior Resident Doctor |
| Affiliation |
King George Medical University Lucknow |
| Address |
Room no 215 RALC Girls Hostel
KGMU Lucknow
Room no 215 RALC Girls Hostel
KGMU Lucknow
Lucknow
UTTAR PRADESH
226018
India |
| Phone |
7351325457 |
| Fax |
|
| Email |
reetisharma777@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University Lucknow 226003 UP India |
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Lucknow 226003 |
| Type of Sponsor |
Government 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 Reeti Sharma |
King George Medical University Lucknow |
Department of Anaesthesia
King George Medical University Lucknow 226003
Lucknow
UTTAR PRADESH |
7351325457
reetisharma777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the patients in age group 18-65 years of age admitted to ICU within 24 hours of trauma with polytrauma and Injury severity score of more than 16
Giving consent for participation |
|
| ExclusionCriteria |
| Details |
Patient died within 48 hours
Pregnant females
Patients with co existing diseases like diabetes coronary artery disease renal failure liver dysfunction alcoholism malignancy epilepsy seizures acute pancreatitis and drugs like epinephrine metformin nucleotide analogue
Leave against medical advice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate correlation between baseline and peak values of serum lactate and serum calcium with mortality in polytrauma patients |
From admission of patients every 24 hourly till discharge or transfer from ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate correlation of serum lactate & serum calcium with
APACHE II SOFA & ISS
Number of patients on mechanical ventilation
Total number of in hospital mortality
Number of days of ICU stay |
From admission of patients 24 hourly till discharge or transfer from ICU |
|
|
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)
|
10/11/2025 |
| 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="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
|
The study is designed to study the correlation between baseline and peak values of serum calcium and serum lactate with mortality in polytrauma patients. patients admitted to the ICU within 24 hours of trauma will be included in the study and will be followed up till discharge or transferred from ICU and daily measurements of serum calcium serum lactate and SOFA score will be done. |