| CTRI Number |
CTRI/2024/12/078372 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hypomagnesemia in citically ill patients admitted in icu |
|
Scientific Title of Study
|
Prevalance of Hypomagnesemia in Crtically Ill Patients admitted in ICU: an 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 |
Dr Saurav Shekhar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesia
Trauma & Emergency
IGIMS
Patna
BIHAR
800014
India |
| Phone |
09308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurav Shekhar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesia
Trauma & Emergency
IGIMS
BIHAR
800014
India |
| Phone |
09308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurav Shekhar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
TRAUMA & EMERGENCY
IGIMS
BIHAR
800014
India |
| Phone |
09308921568 |
| Fax |
|
| Email |
sauravshekhar99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Trauma & Emergency
Indira Gandhi Institute of Medical Sciences
Patna 800014
bihar |
|
|
Primary Sponsor
|
| Name |
DR SAURAV SHEKHAR |
| Address |
Dept of Anesthesiology
Trauma & Emergency
IGIMS
Patna |
| 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 |
| Dr Saurav Shekhar |
Indira Gandhi Institute of Medical Sciences |
DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY)
IGIMS
PATNA
Patna
BIHAR |
09308921568
sauravshekhar99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, (2) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
0 |
| Comparator Agent |
nil |
0 |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted in icu with sepsis
both sexes
|
|
| ExclusionCriteria |
| Details |
patients refusal
any patients with condition causing magnesium abnormality |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalance of hypomagnesemia in critically ill patients. |
0 days, 48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
corelation of hypomagnesemia with icu number of days
28 days mortality
|
0 days , 48 hrs, 28 days |
|
|
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)
|
29/12/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
magnesium is the ion of the century |