| CTRI Number |
CTRI/2023/07/054731 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of life threatening complication of uncontrolled blood sugars |
|
Scientific Title of Study
|
Clinical Profile of Diabetic Ketoacidosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya C |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , MAHE |
| Address |
Department of General Medicine, Kasturba Medical College , Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9611232078 |
| Fax |
|
| Email |
shwarya.c94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananthakrishna Shastri |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College , MAHE |
| Address |
Department of General Medicine, Kasturba Medical College , Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845702450 |
| Fax |
|
| Email |
ba.shastry@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya C |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , MAHE |
| Address |
Department of General Medicine, Kasturba Medical College , Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9611232078 |
| Fax |
|
| Email |
shwarya.c94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal |
| 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 Aishwarya C |
Kasturba Hospital, Kasturba Medical College, Manipal |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9611232078
shwarya.c94@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E081||Diabetes mellitus due to underlying condition with ketoacidosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Serum glucose >250mg /dl ( < 250 in case of Euglycemic ketoacidosis ) 2. Serum bicarbonate concentra)on < 18 mmol/L
3. Arterial pH <7.3
4. Overt or significant ketonuria (more than 2+) |
|
| ExclusionCriteria |
| Details |
1.Post cardiopulmonary resuscitated patients
2.Late stages og CKD
3.Decompensated Chronic liver disease
4.Ketotic state like starvation ketosis, alcoholic ketosis, alcoholic ketosis
5.Drug or toxin induced acidosis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Analyse the clinical presentation and the risk factors precipitating Diabetic Ketoacidosis. |
AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Analyse the biochemical profile of Diabetic Ketoacidosis
1.Co-relate the HbA1C levels with severity of Diabetic Ketoacidosis.
2.Assess the complications & prognosis of Diabetic Ketoacidosis.
3.Study the outcomes of Diabetic Ketoacidosis patients during treatment.
4.Analyse the frequency of euglycemic ketoacidosis ,clinical & biochemical profile of euglycemic ketoacidosis & prognosis of the same. |
at baseline & discharge or death |
|
|
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)
|
04/07/2023 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The changing demographics of diabetes necessitates a need to analyse and evaluate the risk factors and clinical presentation of patients with ketoacidosis.There is an increasing frequency of euglycemic ketoacidosis due to introduction of SGLT2 inhibitors in the management of diabetes . Hence , this study aims to analyse the clinical presentation and the risk factors precipitating Diabetic Ketoacidosis, To analyse the biochemical profile of Diabetic Ketoacidosis, to co-relate the HbA1C levels with severity of Diabetic Ketoacidosis, to assess the complications and prognosis of Diabetic Ketoacidosis, To study the outcomes of Diabetic Ketoacidosis patients during treatment,To analyse the frequency of euglycemic ketoacidosis , clinical and biochemical profile of euglycemic ketoacidosis and prognosis of the same. |