| CTRI Number |
CTRI/2024/01/062093 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of occurrence of low magnesium and its effect on clinical outcome in severly ill patients. |
|
Scientific Title of Study
|
Study of prevalence of hypomagnesemia and its effect on clinical outcome in Critically ill patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithanya P P |
| Designation |
Primary DNB Postgraduate,Department of General Medicine |
| Affiliation |
Dr TMA Pai Hospital |
| Address |
Dr TMA Pai Hospital, Department of General Medicine, Udupi, Karnataka
Udupi
KARNATAKA
576101
India |
| Phone |
8714589281 |
| Fax |
|
| Email |
chaithanyajanardhan96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHASHIKIRAN UMAKANTH |
| Designation |
Professor and Head,Department of General Medicine |
| Affiliation |
Dr TMA Pai Hospital |
| Address |
Dr TMA Pai Hospital, Department of General Medicine, Udupi, Karnataka
Udupi
KARNATAKA
576101
India |
| Phone |
9008418171 |
| Fax |
|
| Email |
shashikiran.u@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chaithanya P P |
| Designation |
Primary DNB Postgraduate,Department of General Medicine |
| Affiliation |
Dr TMA Pai Hospital |
| Address |
Dr TMA Pai Hospital, Department of General Medicine, Udupi Karnataka
Udupi
KARNATAKA
576101
India |
| Phone |
8714589281 |
| Fax |
|
| Email |
chaithanyajanardhan96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr TMA Pai Hospital, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr TMA Pai Hospital |
| Address |
Court Road,Udupi, Karnataka |
| Type of Sponsor |
Private 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 Chaithanya P P |
Dr TMA Pai Hospital |
Department of General Medicine,1st Floor,Udupi
Udupi
KARNATAKA |
8714589281
chaithanyajanardhan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, (2) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who are critically ill
Age above 18 years
Admitted to ICU or HDU
APACHE II SCORE 18 or more |
|
| ExclusionCriteria |
| Details |
Patients who are given magnesium infusion during the current or within last 24-48 hrs
Patients who received blood products within 24-48hrs
Patients who had burns injury within last 4 weeks.
Patients with acute or chronic renal failure on dialysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The result will be used to determine the prevalence of hypomagnesemia in critically ill patients admitted to ICU & HDU and to determine outcome like need for mechanical ventilation,early extubation,hospital stay,mortality.
Critically ill patients identified through APACHE II score |
12 months & 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine association of hypomagnesemia with other electrolytes(calcium and pottasium) |
12 & 18 months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
10/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a Prospective Observational time bound study, 144 patients are included in this study who are critically ill,as per APACHE II criterias,admitted to ICU & HDU of Dr TMA Pai Hospital will be studied,serum Magnesium levels in this patients at time of admission and during hospital stay will be monitored.The prevalence of hypomagnesenia in this patients will be noted.The outcome in such patients will be assessed.The need for ICU admission,mechanical ventilation,longer hospital stay in this patients will be determined. Further with this study relation of other electrolyte levels like of calcium and potassium in hypomagnesemia will be assessed. |