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CTRI Number  CTRI/2025/03/082993 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Monitoring Blood Pressure Changes and Lactate Levels in Off-Pump Coronary artery Bypass Surgery: An Observational Study 
Scientific Title of Study   Measurement of Central Venous Pressure and Pulse Pressure Variations in Off-Pump CABG Surgeries and Their Correlation with Lactate Levels: An Observational Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gopinath S 
Designation  Full time PG student 
Affiliation  SRM Medical College Hospital And Research Centre 
Address  Department of Anesthesiology, MSC, Anesthesia Technology branch, SRM Medical College Hospital And Research Centre, SRM Nagar, Kattankulathur. Potheri Chengalpattu Tamil Nadu
No. 17/7 Keeraikara street Tindivanam Villupuram district 604001
Viluppuram
TAMIL NADU
603203
India 
Phone  7708364896  
Fax    
Email  gopinathshankar95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Gayathri B, M.B.B.S, MD Anaesthesiology 
Designation  Professor and the Head of the department Anaesthesiology  
Affiliation  SRM Medical College Hospital And Research Centre 
Address  Department of Anesthesiology, SRM Medical College Hospital And Research Centre SRM Nagar, Potheri Chengalpattu Tamil Nadu 603203
Department of Anesthesiology, SRM Medical College Hospital And Research Centre SRM Nagar Potheri Chengalpattu Tamil Nadu 603203
Kancheepuram
TAMIL NADU
603203
India 
Phone  9500092905  
Fax    
Email  gayathrb@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gayathri B MBBS MD ANESTHESIOLOGY  
Designation  Professor and Head, 
Affiliation  SRM Medical College Hospital And Research Centre 
Address  Department of Anesthesiology, SRM Medical College Hospital And Research Centre SRM Nagar Potheri Chengalpattu Tamil Nadu 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9500092905  
Fax    
Email  gayathrb@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital And Research Centre, Chennai, India, 603203 SRM Nagar Potheri Chengalpattu Tamil Nadu 603203 
 
Primary Sponsor  
Name  Gopinath S 
Address  SRM Medical College Hospital And Research Centre SRM Nagar Potheri Chengalpattu Tamil Nadu 603203 
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 Gayathri B MBBS MD  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE  SRM Medical College Hospital And Research Centre SRM Nagar Potheri Chengalpattu Tamil Nadu 603203
Kancheepuram
TAMIL NADU 
09500092905

gayathrb@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital And Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All adult patients age undergoing off pump CABG surgery at SRM Medical college hospital will be included in this study 
 
ExclusionCriteria 
Details  Pre operative Ionotropic support
Preoperative Intra Aortic ballon pump support
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the correlation between a pulse pressure variation and central venous pressure with lactate levels in off-pump coronary artery bypass grafting surgeries.   1. Baseline
2. 1 hr after starting the surgery
3. Every one hour lactate level and Pulse pressure variations is measured till the end of the surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the correlation between a pulse pressure variation and central venous pressure with Inotropic requirements, Duration of mechanical support and Morbidity.  Perioperative period, ionotrophic support is noted every half an hour. till patient discharge. Lactate levels are noted 3 times in a day 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   21/03/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

STUDY JUSTIFICATION:

Central venous pressure (CVP) and pulse pressure variations (PPV) are widely recognized as standard measures of a patient’s volume status, particularly in perioperative  settings. These parameters are routinely monitored during coronary artery bypass graft (CABG) surgeries to ensure optimal fluid management and hemodynamic stability.

In the context of cardiac surgeries, particularly CABG, both CVP and PPV can be influenced by a variety of factors such as cardiac function, myocardial contractility, and the surgical manipulation of the heart. Given the complexity of these procedures, the accuracy of these parameters in reflecting true intravascular volume and tissue perfusion can be variable.

One of the critical markers of tissue oxygenation during surgery is the level of lactate in arterial blood gas (ABG) measurements. Elevated lactate levels are indicative of tissue hypoperfusion and anaerobic metabolism, often signaling inadequate oxygen delivery to tissues. This makes lactate a crucial parameter to monitor, as it provides direct insight into the adequacy of tissue oxygenation.

The objective of this study is to determine which of the two hemodynamic parameters—central venous pressure (CVP) or pulse pressure variations (PPV)—has a stronger correlation with lactate levels during CABG surgeries. By identifying the parameter that more accurately reflects tissue oxygenation, we aim to improve intraoperative monitoring and patient outcomes.

Study Hypothesis & Research Question:

HYPOTHESIS:  Given its dynamic nature, we hypothesize that pulse pressure variations (PPV) may serve as a more reliable indicator of volume status during coronary artery bypass graft (CABG) surgeries compared to central venous pressure (CVP). Unlike CVP, which is a static measure, PPV reflects real-time changes in preload and cardiac output, making it potentially more sensitive to fluctuations in intravascular volume.

We postulate that because PPV is more responsive to changes in cardiac preload and contractility, it may correlate more closely with serum lactate levels than CVP. If our hypothesis is correct, PPV could provide a better real-time assessment of the patient’s volume status and tissue perfusion during CABG surgeries, leading to more informed clinical decisions and improved patient care.

METHODOLOGY:

 

SITE OF THE STUDY: Study conducted inside sterile in operation theatres SRM Medical College Hospital and Research centre.

 

STUDY POPULATION: All adult patients who were undergoing surgery under OFF-PUMP CABG surgeries a patient who meets inclusion criteria.

SAMPLE SIZE: 88

TYPE OF STUDY: Prospective Observational Study

STUDY TOOLS: Hemodynamic parameters MULTIPARAMETER – PHILLIPS INTELLIVUE MX 550 SYSTEMS.

MATERIALS AND METHOD:

Patients admitted for surgical procedures under general anaesthesia will be included in the study after getting informed consent from them. Patients particulars like Age, Sex, Height, Weight, BMI, ASA status and surgical procedure to be recorded.

The following data surgery related characteristics will be recorded for the all patients

The patients who qualify as per the selection criteria will be given a clear explanation regarding the anaesthesia procedure in their vernacular language.

Demographic data: Age, Sex, Height, Weight, BMI, ASA status Including preop investigations (EF, Serum creatinine, Hb% and urea levels)

Informed consent will be obtained from the patients for elective surgery will be kept fasting  for 8 to 10 hours prior to General anaesthesia surgery and premedicated with Tab. Alprazolam 0.25 mg HS in the night prior to the day of surgery accordingly.

The following data will be collect from the case record before patient shift to the operation theatre. On arrival in the operating theatre, Patients will be Placed supine, start a cannulisation will be done on nondominant hand 18-G and arterial line on Left hand radial artery with BD cannula 16-G and cannula to be secure properly.

An intravenous line will be secure, IV fluid volume Drugs and doses determined by the anaesthesiologist preference.

ECG, pulse oximetry and blood pressure measurement, invasive BP, PPV baseline monitoring initiate and to be monitor.

After application of the routine hemodynamic monitoring according to institutional standards (pulse oximetry, five-lead ECG, and invasive BP monitoring [Multiparameter- Philips IntelliVue MX550 Systems) prior to the induction

Pre-oxygenation will be conduct for a minimum of 3 minutes.

100% oxygen via a tight-fitting facemask with a fresh gas flow of 6 l/min delivery of via a circle system.

All patients included in the study had a standardized anaesthesia technique as per cardiac anaesthesia unit protocol. A balanced anaesthesia technique with midazolam (0.1mg/kg), etomidate (0.1–0.3 mg/kg), with fentanyl (3 mcg/kg) and nondepolarizing muscle relaxants (vecuronium-0.1mg/kg) and Sevoflurane were used for induction of anaesthesia. Anaesthesia was maintain with air, oxygen, and with incremental doses of fentanyl and muscle relaxant.

After induction of the patient under aseptic technique CVP line inserted through the Internal jugular vein site with using of [7 Fr 16 cm with triple lumen is secure] and Base line CVP monitoring to be start and documentation of the intraoperative recording measurements.

Following endotracheal intubation, mechanical ventilation was perform without positive end-expiratory pressure using an inspired oxygen concentration of 50% and tidal volumes of 10 mL/kg to maintain an end expiratory Pco2 at 4 to 4.5 kPa during the study period.

Effectively apply mean tidal volumes, and positive end expiratoryendsexpiratory positive pressures ranged from 4 to 8cm H2O.

Surgical data: Duration of surgery, Arterial BP, MAP, PPV, lactate levels, CVP, Inotropic requirements, IV fluids & Blood products, Urine output, Temperature and Blood loss.

 

Continuous monitoring: Every 1/2 half hour intraoperatively monitoring and recording the patients’ vital parameters IBP, Central venous pressure, Pulse pressure variations, Systolic BP, Diastolic BP, Mean arterial pressure, Urine output, Temperature.

Monitoring of Serum lactate level before induction and intraoperatively and Blood loss, urine output, Input (Blood products, colloids & crystalloids), duration of the surgery and inotropic requirements. Post operatively: Duration of the mechanical ventilation, Creatinine and Urea levels,  POSTOP - Serum lactate levels up to patient Extubating period, Any mortality and morbidity is noted.

 
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