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CTRI Number  CTRI/2021/02/031134 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 24/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effect of obesity in open cardiac surgeries. 
Scientific Title of Study   Effect of obesity on perioperative and post-operative outcomes in open cardiac surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamidi Amarnath Babu 
Designation  Junior Resident- Department of General surgery 
Affiliation  Kasturba Medical college 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal, Udupi-576104
Madhav Nagar, Manipal, Udupi-576104
Udupi
KARNATAKA
576104
India 
Phone  9440083388  
Fax    
Email  mamidi.babu@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr K Veena L Karanth 
Designation  Professor and Unit chief- Department of General surgery 
Affiliation  Kasturba Medical College 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal, Udupi-576104
Madhav Nagar, Manipal, Udupi-576104
Udupi
KARNATAKA
576104
India 
Phone  9845417715  
Fax    
Email  veena.karanth@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Kumar Bishnoi 
Designation  Professor- Cardiothoracic Surgery  
Affiliation  Kasturba Medical college 
Address  Department of CVTS, Room number 32, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal, Udupi-576104
Madhav Nagar, Manipal, Udupi-576104
Udupi
KARNATAKA
576104
India 
Phone  9429314718  
Fax    
Email  arvind.bishnoi@manipal.edu  
 
Source of Monetary or Material Support  
Department of CVTS, Kasturba Hospital, Manipal. 
 
Primary Sponsor  
Name  Dr Veena L Karanth 
Address  Department of General surgery, 3rd floor, Smt.Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal, Udupi-576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Bishnoi  Department of CVTS, Kasturba hospital , Manipal   Department of CVTS, Room number 32, Smt. Sharada Madhav Pai OPD Building, Kasturba Hospital, Manipal, Udupi-576104
Udupi
KARNATAKA 		 9429314718

arvind.bishnoi@manipal.edu 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  CABG surgeries, Valve Surgeries 
 
ExclusionCriteria 
Details  Emergency cardiac surgeries, Congenital heart diseases, Transplant surgeries, Ejection Fraction < 40% patients, Pre-existing pulmonary conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Non-obese patients are expected to have more likely better outcome as compared to obesity patients  10 days  
 
Secondary Outcome  
Outcome  TimePoints 
Non-obese patients have less rate of surgical site infections, septicemia, pneumonia, prolonged ventilation, post operative stroke, acute kidney injury requiring dailysis, length of stay compared to obese patients  10days 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   10/02/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Peers involved in the manuscript review for publication and any regulatory authority

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  The data will be sent on written request by the Editor of the Joiurnal or Head of the regulatory authority

  6. For how long will this data be available start date provided 10-02-2021 and end date provided 10-02-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a prospective observational study which will be conducted at Kasturba hospital affiliated by Kasturba Medical College, Manipal. Written informed consent will be taken from each study subject at the time of enrolment.  A total of 104 consecutive patients who are having open heart surgery at Kasturba hospital were included after fulfilling the inclusion and exclusion criteria. All patients are being operated by the same surgical team using the standard anesthesia and cardiopulmonary bypass techniques. Standard data will be collected during patients’ admissions as part of routine clinical practice in our institution. Body mass index is calculated by using the following formula: BMI= weight (kg) / height2 (m2).Lab investigation reports will be collected from the routine lab investigations which are done during the admission required for surgery  Observation of the patients will be done by using the data collection tool/proforma. 
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