| CTRI Number |
CTRI/2020/05/025376 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
06/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of management of high blood sugar levels before, during and after operations
period in surgical patients of a tertiary care hospital. |
|
Scientific Title of Study
|
Evaluation of management of hyperglycemia during perioperative
period in surgical patients of a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
SETH G.S Medical college and KEM Hospital |
| Address |
Department of Pharmacology and Thearapeutics,K.E.M Hospital and Seth G.S Medical College, Acharya Dongre Marg, Parel, Mumbai
Acharya Dongre Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920069601 |
| Fax |
02224155678 |
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
K.E.M Hospital and Seth G.S Medical College |
| Address |
Department of Pharmacology and Thearapeutics, K.E.M Hospital and Seth G.S Medical College, Acharya Dongre Marg, Parel, Mumbai
Acharya Dongre Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920069601 |
| Fax |
02224155678 |
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
SETH G.S Medical college and KEM Hospital |
| Address |
Department of Pharmacology and Thearapeutics,K.E.M Hospital and Seth G.S Medical College, Acharya Dongre Marg, Parel, Mumbai
Acharya Dongre Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920069601 |
| Fax |
02224155678 |
| Email |
yashashrirajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diamond Jubilee Society Trust,KING EDWARD MEMORIAL HOSPITALSETH GORDHANDAS SUNDERDAS MEDICAL COLLEGE,Acharya Donde Marg, Parel,
Mumbai 400 012. |
|
|
Primary Sponsor
|
| Name |
DJST |
| Address |
Seth G.S Medical College and KEM hospital,parel |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Namra Sayed |
Seth G.S Medical COllege |
room no 1, Department of Pharmacology and Therapeuics,Acharya Donde Marg, Parel,
Mumbai 400 012. India.
Mumbai
MAHARASHTRA |
9326312902
namrasayed12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Seth G.S Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients within the age range of 18years -75years.
2. Patients of either gender.
3. Patients admitted to General surgery and Orthopaedics ward.
4. Patients who are known diabetics or hyperglycaemic and have undergone elective or
emergency non-cardiac surgery during duration of the study period will be included in the
study.
5. Patients/LAR who are willing to consent for the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the practice of use of Oral Hypoglycemic agents /Insulin in
hyperglycemic patients in perioperative setting.
|
24 hours post-operatively or before discharge of patient whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To find out the change in drug, dose, dosage form of antidiabetic
medication from pre operative to operative and to post-operative
setting.
2)To find out commonest co-morbid condition (Hypertension) and its
management.
3)To assess the blood glucose control in operative setting.
4)To find the influence of other drugs (beta blockers, thiazides and
corticosteroids)if used on blood glucose control
5)To find the usage of IV Fluids in operative setting |
24 hours post-operatively or before discharge of patient whichever is earlier. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
06/06/2020 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes is prevelant condition in India and worldwide.There are no specific Guidelines and very few studies in India which which elaborate on the management of diabetic Patients in Surgical setting during Peri-operative Period.Thus the study is being Planned. |