| CTRI Number |
CTRI/2022/02/040668 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
26/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Carboload drink] |
| Study Design |
Other |
|
Public Title of Study
|
To study the safety and efficacy of preoperative Oral Carbohydrate Loading in Type 2 Diabetic patients undergoing Off Pump - Coronary Artery Bypass Grafting (OPCAB) |
|
Scientific Title of Study
|
To study the safety and efficacy of preoperative Oral Carbohydrate Loading in Type 2 Diabetic patients undergoing Off Pump - Coronary Artery Bypass Grafting (OPCAB) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sree Ram R |
| Designation |
PG Resident |
| Affiliation |
Aster Medcity |
| Address |
Anesthesiology
Aster medcity,
Kuttisahib Road Cheranelloor, South Chittoor, Kochi
Ernakulam
Ernakulam
KERALA
682027
India |
| Phone |
09446326675 |
| Fax |
|
| Email |
sreeram1432011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeeth p s |
| Designation |
Consultant |
| Affiliation |
Aster Medcity |
| Address |
Anaesthesiology
Aster medcity
Kuttisahib Road Cheranelloor, South Chittoor, Kochi
Ernakulam
Ernakulam
KERALA
682027
India |
| Phone |
09446326675 |
| Fax |
|
| Email |
drsangeethps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sree Ram R |
| Designation |
PG Resident |
| Affiliation |
Aster Medcity |
| Address |
Anaesthesiology
Aster medcity
Kuttisahib Road Cheranelloor, South Chittoor, Kochi
Ernakulam
Ernakulam
KERALA
682027
India |
| Phone |
09446326675 |
| Fax |
|
| Email |
sreeram1432011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster Medicity, Kuttisahib Road, Ernakulam |
|
|
Primary Sponsor
|
| Name |
Aster Medcity |
| Address |
Kuttisahib road
Ernakulam |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Sree ram R |
Aster Medicity |
Anesthesia Department
Kuttisahib road
Ernakulam
Ernakulam
KERALA |
9446326675
sreeram1432011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aster Medicity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To know the safety and efficacy of preoperative Oral Carbohydrate Loading in Type 2 Diabetic patients undergoing Off Pump - Coronary Artery Bypass Grafting (OPCAB) |
Giving 400ml of carbohydrate drink on day before surgery night at 10pm and the residual gastric volum calculated on the day of surgery at 8am. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetic patients undergoing Off Pump - Coronary Artery Bypass Grafting (OPCAB) |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2. Severe LV dysfunction (EF < 30%)
3. Emergency surgeries
4. Patients with BMI >30
5. Patients with known autonomic neuropathy or gastroparesis
6. Patients with anticipated difficult airway
7. HBA1C > 9% |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Residual gastric volume |
For 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Adequacy of glycemic control
2) Requirements of insulin in intraoperative and postoperative period
3) Hemodynamic chnages
4) Acute phase changes including C Reactive proteins and serum albumin
5) Subjective symptoms of thirst, hunger, anxiety and pain
6) Inotrope and vasopressor score.
7) Incidence of infection, renal failure and other complications |
vas SCORE 1-10
For 24hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2022 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Prospective, single center, non blinded randomized controlled study to know the safety and efficacy of preoperative Oral Carbohydrate Loading in Type 2 Diabetic patients undergoing Off Pump - Coronary Artery Bypass Grafting (OPCAB). Purpose is to know whether the safety of oral carbohydrate loading |