| CTRI Number |
CTRI/2024/08/071833 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective Comparative Study use of plasmalyte vs volulyte as priming solution on cardiac bypass during cardiac surgery |
|
Scientific Title of Study
|
Prospective Comparative Study use of plasmalyte (crystalloid )vs volulyte (colloid )as priming solution on cardiac bypass during cardiac surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishalakshi Tekale |
| Designation |
Junior Resident |
| Affiliation |
Dy patil Hospital and School of medicine |
| Address |
DY patil school of medicine, Department of anaesthesia , Ayyappa temple road
Mumbai
MAHARASHTRA
400706
India |
| Phone |
7382696982 |
| Fax |
|
| Email |
Shaly18499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
Dy patil hospital and school of medicine |
| Address |
Dr Dy Patil hospital and school of medicine , Ayyappa road , Vidyanagar , sector 5 , Nerul , Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
Dy patil hospital and school of medicine |
| Address |
Dr Dy Patil hospital and school of medicine , Ayyappa road , Vidyanagar , sector 5 , Nerul , Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dy patil hospital and school of medicine
Vidyanagar, sector 5 , Nerul , Navi Mumbai , PIN code -400706 |
|
|
Primary Sponsor
|
| Name |
Dr Manjula Sarkar |
| Address |
Dr Dy Patil hospital and school of medicine ,Ayyappa temple road , Vidyanagar ,sector 5 , Nerul , Navi Mumbai |
| Type of Sponsor |
Other [Guide and professor ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Vishalakshi Tekale |
DY Patil hospital and school of medicine |
Dy Patil hospital and school of medicine, Ayyappa temple road , Vidyanagar , sector 5 , Nerul , Navi Mumbai
Mumbai
MAHARASHTRA |
7382696982
Shaly18499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Biomedical and Health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent
Patient admitted for cardiac surgery |
|
| ExclusionCriteria |
| Details |
Patient who are pregnant or lactating
Patients coming for emergency cardiac surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of PH on body by different types of priming solution |
From the addition of priming solution on pump till 30 minutes after the patient has been shifted to icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate electrolytes and hemodynamic response and blood sugars |
30 minutes after patient is shifted to icu |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cardiopulmonary bypass circuit should be primed with fluid so that adequate flow rates can be achieved after the initiation of the cardiopulmonary bypass pump without the risk of air embolism , fluid used should be close to the physiological ph of the human body |