| CTRI Number |
CTRI/2024/01/061997 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Compare the peripheral perfusion index and serum lactate levels as a marker of tissue perfusion in patients undergoing elective open heart surgery with cardiopulmonary bypass |
|
Scientific Title of Study
|
“Comparison of peripheral perfusion index and serum lactate levels as a marker of tissue perfusion in patients undergoing elective open heart surgery under cardiopulmonary bypass†|
| Trial Acronym |
Peripheral Perfusion Index |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen Malhotra |
| Designation |
Senior Professor and Head |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Cardiac Anesthesia,Pt BD Sharma PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9812091051 |
| Fax |
|
| Email |
drnaveenmalhotra@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Chandra |
| Designation |
DM Cardiac Anesthesia (Student) |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Cardiac Anesthesia,Pt BD Sharma PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9674175008 |
| Fax |
|
| Email |
pcsgpgi123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Chandra |
| Designation |
DM Cardiac Anesthesia (Student) |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Cardiac Anesthesia,Pt BD Sharma PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9674175008 |
| Fax |
|
| Email |
pcsgpgi123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of cardiac anesthesia
Pt BD Sharma PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Dr Prakash Chandra |
| Address |
Department of Cardiac Anesthesia,Pt BD Sharma PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Prakash Chandra |
Pt BD sharma PGIMS Rohtak |
Ward 31 Department of cardiac anesthesiology
Rohtak
HARYANA |
9674175008
pcsgpgi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with American Society of Anaesthesiologists Physical Status 3 or 4 of age 20 to 60 years planned for elective open heart surgery under cardiopulmonary bypass |
|
| ExclusionCriteria |
| Details |
Patients with history of severe hepatic renal dysfunction and Chronic obstructive pulmonary disease with FEV1 less than 50 percent
Patients with cyanotic heart disease
Patients with left ventricular ejection fraction less than 40 percent
Patients undergoing combined surgical procedures CABG combined with valve surgery or aortic procedures and carotid surgery
Redo-procedures within one year of previous surgery
Patients with serum lactate more than 3 mmol per litre preoperatively
Patients with BMI of more than 32 kg per meter square
Pregnant patients
Patients with sepsis and shock states
Patients with nail pathologies
Patients in whom modified Allens test could not be performed or is negative
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and correlate the peripheral perfusion index with serum lactate levels |
T1 preCPB
T2 cooling
T3 hypothermia
T4 rewarming
T5 post- CPB
T6 6 hours postoperatively
T7 12 hours postoperatively
T8 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate changes in peripheral perfusion index & serum lactate values with changes in haemodynamic indices |
T1 pre CPB
T2 cooling
T3 hypothermia
T4 rewarming
T5 post- CPB
T6 6 hours postoperatively
T7 12 hours postoperatively
T8 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2024 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The primary purpose of the protocol is to correlate the peripheral erfusion index with serum lactate levels in cardiac surgeries involving use of cardiopulmonary bypass. We have hypothesised that there will be early change in perfusion index prior to the change in serum lactate levels.By knowing the correlation we can take steps to avoid to increase hypoperfusion time and rule out the cause and manage accordingly. |