| CTRI Number |
CTRI/2011/10/002066 [Registered on: 14/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
23/06/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Steroids in cardiac surgery |
|
Scientific Title of Study
|
Steroids In caRdiac Surgery |
| Trial Acronym |
SIRS trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20100129 |
Protocol Number |
| NCT00427388 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Karthikeyan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Cardiology All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26594464 |
| Fax |
26588641 |
| Email |
karthik_2010@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balram Airan |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Professor
Room no 24,7th floor,Department of Cardiology, C.N.Centre, All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26594464 |
| Fax |
26588641 |
| Email |
iactscon_2004@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Karthikeyen |
| Designation |
|
| Affiliation |
|
| Address |
Department of Cardiology All India Institute of Medical Sciences
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26588500*4464 |
| Fax |
26588641 |
| Email |
karthik2010@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Population Health Research Institute McMaster UniversityHamilton |
| Address |
David Braley Cardiac, Vascular and Stroke Research Institute
Hamilton General Hospital
237 Barton Street East
Hamilton, ON L8L 2X2 CANADA
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Greece
Hungary
India
Ireland
Italy
Spain
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balram Airan |
A.I.I.M.S. |
Room no. 24 7th floor Department of cardiology C.N.Centre AIIMS
South
DELHI |
011-26594464
91-11-26588641
iactscon_2004@yahoo.co.in |
| DrShiv Kumar Nair |
Amrita Institute Of Medical Sciences |
Dr. Shiv K. Nair
Professor and Head
Department of Cardiovascular and Thoracic Surgery
Amrita Institute of Medical Sciences
Ponekkara
Kochi
Kerala - 682 041
Pathanamthitta
KERALA |
09895649041
rsd1235@aims.amrita.edu |
| Dr Vinayak Shukla |
Christian Medical College and Hospital |
Professor and head Cardiothoracic Surgery Unit 2 CMC Hospital Vellore 632004
Vellore
TAMIL NADU |
0416-2282160
shukla@gmail.com |
| DrBhim Shankar |
Frontier Lifeline |
Frontier Lifeline Hospital
R-30C, Ambattur Industrial Estate Road,
Chennai - 600 101
Chennai
TAMIL NADU |
09790352964
sowmyajoy@gmail.com |
| DrPChandrashekhar |
GKNM Hospital |
Dr Chandrashekhar, Consultant Cardiothoracic Surgeon, GKNM,Coimbatore
Coimbatore
TAMIL NADU |
91-9789199033
chandrasekar@gknmh.org |
| Dr Dharmarakshak |
Nizam,s Institute of Medical Sciences |
Dr. Dharma Rakshak Ayapati
Investigator, SIRS Trial
8-2-120/86/1/A, Road No : 3,
Banjara Hills,
Hyderabad - 500 034, A.P. ,India
Hyderabad
ANDHRA PRADESH |
09440442525
sirsnims@gmail.com |
| Dr Jayakumar |
SCTIMST |
Dr.K.Jayakumar
Professor and Head
Department of Cardiovascular and Thoracic Surgery
Sree Chithra Tirunal institute for Medical Sciences and Technology (SCTIMST)
Medical College PO
Trivandrum - 695011
Kerala
Thiruvananthapuram
KERALA |
09447007678
dr_jay_k@hotmail.com |
| Dr S K Aggarwal |
SGPGI |
Dr S K Aggarwal Additional Professor Department of Cardiovascular and thoracic surgery Raebareli road Lucknow U.P.
Lucknow
UTTAR PRADESH |
09839540579
surendra@sgpgi.ac.in |
| DrRavi S Math |
Sri Jayadeva Institute |
Dr Ravi S Math
Assistant Professor
Departmrnt of Cardiology
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bannerghatta Road,
Jayanagar 9th Block
Bangalore 560069
Bangalore
KARNATAKA |
09535108410
ravismath@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| AIIMS,New Delhi |
Approved |
| Amrita Institute of Medical Sciences,Cochin |
Approved |
| Christian Medical College & Hospital,Vellore |
Approved |
| Frontier Lifeline,Chennai |
Approved |
| GKNM Hospital,Coimbatore |
Approved |
| Nizams Institute of Medical Sciences,Hyderabad |
Approved |
| SCTIMST,Trivandrum |
Approved |
| SGPGI,Lucknow |
Approved |
| Sri Jayadeva Institute,Banglore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cardiopulmonary Bypass Surgery , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Methylprednisolone |
500mg. in division of 250mg twice during anesthesia procedure prior to surgery and route of administration will be intravenous. |
| Comparator Agent |
Placebo |
500mg. in division of 250mg twice during anesthesia procedure prior to surgery and route of administration will be intravenous. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years
2.Reqire CPB for any cardiac surgical procedure (such as CABG,Valve,Arota or combined procedures)
3.Euroscore greater than or equal 6
4.Written informed consent |
|
| ExclusionCriteria |
| Details |
1.Use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period (e.g. cardiac transplantation)
2.History of bacterial or fungal infection in the last 30 days
3.Allergy or intolerance to corticosteroids
4.Receving Aprotinin
5.Previous participation in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All cause mortality at 30 days. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant Myocardial injury or death at 30 days |
30 days |
| Efficacy Outcome- All cause mortality at 6 months,new onset atrial fibrilation,transfusion reqirements,bleeding,length of ICU stay and hospital stay. |
6 months |
| Safety outcome- Infection.delirium,stroke,wound complication,GI hemorrhage,GI perforation,postoperative insulin use and peak blood glucose during the first 24 hours after surgery. |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="7500"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized,double blinded,parallel group,multi-center trial comparing the benefit & efficacy of Inj. Methylprednisolone 500mg in division of 250mg twice,once during anesthetic induction & once during the initiation of the CPB in 1000 patients undergoing cardiac surgery that will be conducted in 10 centers in India.The primary outcome measures will be all cause mortality at 30 days.The secondary outcome will be significant Myocardial Injury Or Death At 30 Days;Efficacy Outcome- All Cause Mortality At 6 Months,New Onset Atrial Fibrilation,Transfusion Reqirements,Bleeding,Length Of ICU Stay And Hospital Stay;Safety Outcome- Infection.Delirium,Stroke,Wound Complication,GI Hemorrhage,GI Perforation,Postoperative Insulin Use And Peak Blood Glucose During The First 24 Hours After Surgery. |