| CTRI Number |
CTRI/2024/05/067788 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Compare Various Parameters OF Arterial Blood Gas And Venous Blood Gas in Patients With Diabetic Ketoacidosis. |
|
Scientific Title of Study
|
To Compare Different Parameters Of Arterial Blood Gas (ABG)And Venous Blood Gas (VBG) In Patients With Diabetic Ketoacidosis(DKA) Admitted At Sir T Hospital Bhavnagar- A Cross-Sectional 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 |
Sainath Ratnakar Metkar |
| Designation |
Post Graduate 1st Year Resident Doctor |
| Affiliation |
Sir T Hospital, Bhavnagar,Gujrat. |
| Address |
Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9834009737 |
| Fax |
|
| Email |
sainathmetkar299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna K Lakhani |
| Designation |
Professor And Head Of Depatment Medicine |
| Affiliation |
Sir T Hospital Bhavnagar. |
| Address |
Department of medicine,Government medical college and sir T hospital, bhavnagar, Gujrat-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429707472 |
| Fax |
|
| Email |
lakhani_krishna@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna K Lakhani |
| Designation |
Professor And Head Of Department Medicine |
| Affiliation |
Sir T Hospital Bhavnagar. |
| Address |
Department of medicine,Government medical college and sir T hospital, bhavnagar, Gujrat-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429707472 |
| Fax |
|
| Email |
lakhani_krishna@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Sir Takhtsinhij General Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sainath Ratnakar Metkar |
| Address |
Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001 |
| 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 Sainath Metkar |
Sir Takhtsinhji General Hospital , Bhavnagar |
Department of General Medicine, 62 no OPD,Sir Takhtsinhji General Hospital
Bhavnagar GUJRAT.
Bhavnagar
GUJARAT |
9834009737
sainathmetkar299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Medical College , Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E131||Other specified diabetes mellituswith ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 12 years with Diabetic ketoacidosis who will be admitted under General Medicine department.
|
|
| ExclusionCriteria |
| Details |
1.Patients with chronic kidney disease, acute kidney injury, liver diseases.
2.Pregnant women .
3.Patients having preexisting respiratory illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Compare pH, bicarbonate, pCO2, and base excess levels in ABG and VBG samples admitted under medicine department of Sir T Hospital
2.To compare electrolytes levels in ABG and VBG samples of DKA patients. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare VBG’S reliability for monitoring metabolic acidosis in DKA. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/06/2024 |
| 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="10"
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
|
To Compare Different Parameters of Arterial Blood Gas (ABG)And Venous Blood Gas (VBG) In Patients With Diabetic Ketoacidosis(DKA) Admitted At Sir T Hospital Bhavnagar- A Cross-Sectional Study.ABG is considered an a standard investigation for monitoring of metabolic status in patients.
This study is done to compare ABG and VBG and convenience and correctness of VBG over ABG for monitoring of metabolic acidosis in DKA patients. |