| CTRI Number |
CTRI/2024/08/072833 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Characteristics of Patients with Hypoglycemia Presenting to the Emergency Room |
|
Scientific Title of Study
|
Clinical profile of hypoglycaemic patients presenting in emergency room |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA
Patna BIHAR 801507 India |
| Phone |
9717864257 |
| Fax |
|
| Email |
deepakkumar3090@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepak Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA
Patna BIHAR 801507 India |
| Phone |
9717864257 |
| Fax |
|
| Email |
deepakkumar3090@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepak Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA
Patna BIHAR 801507 India |
| Phone |
9717864257 |
| Fax |
|
| Email |
deepakkumar3090@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna Bihar, India 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
AIIMS Patna Hospital, Phulwarisharif patna bihar, India 801507 |
| 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 Deepak Kumar |
AIIMS patna hospital |
DGB AREA Ground Floor EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA Patna BIHAR |
9717864257
deepakkumar3090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Patna RAC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E15||Nondiabetic hypoglycemic coma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with RBS less than 70 mg/dl on arrival to ED
2. Patients with age more than 16 years
|
|
| ExclusionCriteria |
| Details |
Patient refusal to study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and evaluate the clinical profile of hypoglycemic patients presenting to ED. |
6 hours to 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of hypoglycaemia in diabetic & non-diabetic patients presenting to ED.
To assess the cognitive functions using mini mental status examination (MMSE) scale after treatment.
Hypoglycaemia related morbidity & mortality as a final outcome |
6hours to 7days |
|
|
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)
|
05/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
|
Hypoglycemia is a leading cause of emergency department (ED) visits, particularly in patients with diabetes undergoing intensive blood glucose control. Common symptoms include sweating, dizziness, confusion, and in severe cases, loss of consciousness and seizures. While most studies focus on diabetic patients, hypoglycemia also occurs in non-diabetic individuals due to factors such as prolonged starvation, infections, and organ diseases.
The study aims to assess the clinical profile and underlying causes of hypoglycemia in both diabetic and non-diabetic patients presenting to the ED, filling a gap in current literature, especially regarding non-diabetic cases. The primary objective is to evaluate the clinical characteristics of hypoglycemic patients in the ED. Secondary objectives are to determine the incidence of hypoglycemia in diabetic vs. non-diabetic patients, assess cognitive function post-treatment, and document hypoglycemia-related morbidity and mortality. This prospective, observational study will be conducted at AIIMS Patna over six months, involving patients aged 16 and above with a random blood sugar (RBS) level below 70 mg/dl. Data on demographics, symptoms, causes, treatment, and outcomes will be collected and analyzed. Cognitive function will be assessed using the Mini-Mental Status Examination (MMSE) after treatment. Expected Outcomes are that this study is expected to provide insights into the clinical presentation of hypoglycemia in the ED, identify associated factors, and contribute to the knowledge base for healthcare professionals managing hypoglycemic episodes. Prospective and observational, with a sample size of at least 100 patients, using consecutive sampling. The study will include all eligible patients with hypoglycemia during the study period. |