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CTRI Number  CTRI/2021/08/035506 [Registered on: 06/08/2021] Trial Registered Prospectively
Last Modified On: 14/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   COMPARSION OF BLOOD GAS DIFFERENCE (OXYGEN AND CARBON DIOXIDE LEVELS ) WITH BLOOD LACTATE CLEARANCE IN CRITICALLY ILL PATIENTS ADMITTED IN INTENSIVE CARE UNIT. 
Scientific Title of Study   TO EVALUATE CENTRAL VENOUS TO ARTERIAL CO2 DIFFERENCE /ARTERIAL TO CENTRAL VENOUS O2 RATIO WITH LACTATE CLEARANCE IN PATIENTS WITH SEPTIC SHOCK 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Malviya 
Designation  Head of Department of anaesthesiology 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Dr Ram Manohar Lohia Institute of Medical Sciences,Department of Anesthesiology,Vibhuti Khand,Gomti Nagar Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007063   
Fax    
Email  drdm58@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Malviya 
Designation  Head of Department of anaesthesiology 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Dr Ram Manohar Lohia Institute of Medical Sciences,Department of Anesthesiology,Vibhuti Khand,Gomti Nagar Lucknow UTTAR PRADESH 226010 India

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007063   
Fax    
Email  drdm58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kavya sindhu 
Designation  Junior resident  
Affiliation  Dr. Ram manohar lohia institute of medical sciences  
Address  Dr.RMLIMS ,VIBHUTHI KHAND, GOMTI NAGAR,LUCKNOW

Lucknow
UTTAR PRADESH
226010
India 
Phone  9866365942  
Fax    
Email  kavyambbs552@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ram manohar lohia institute of medical sciences, vibhuthi khand, Gomti nagar, Lucknow  
 
Primary Sponsor  
Name  Dr Ram Manohar Lohia Institute of Medical Sciences  
Address  Dr Ram Manohar Lohia Institute of Medical Sciences,Department of Anesthesiology,Vibhuti Khand,Gomti Nagar,Lucknow  
Type of Sponsor  Research institution and hospital 
 
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 Deepak Malviya  Dr.RMLIMS  Room no.826, Dr.sc roy hostel, Dr.RMLIMS ,VIBHUTHI KHAND, GOMTI NAGA, LUCKNOW
Lucknow
UTTAR PRADESH 		 8176007063

drdm58@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I998||Other disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients in septic shock
2. Consent for participation from guardian
3. Patients with central venous line insitu
 
 
ExclusionCriteria 
Details  1. Declined consent from the guardian
2. Pregnant patient
3. Patients with pre existing liver or kidney disease
4. Patients with incomplete data. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and lactate clearance   The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and lactate clearance at baseline, 8 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To define a cut offvalue for the P(cv-a)CO2/D(a-cv)O2 ratio to identify lactate clearance at 8 & 24 hrs respectively after resuscitation   8 hrs and 24 hrs 
 
Target Sample Size   Total Sample Size="100"
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   N/A 
Date of First Enrollment (India)   15/08/2021 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Aims and objectives

The present study is aimed to evaluate

1.The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and LC for 8 and 24 hours and
2. To define a cutoff value for the P(cv-a)CO2/D(a-cv)O2 ratio to identify an 8 and 24-hour LC at 10% and 20% respectively after resuscitation

Research question
Venous-to-arterial PCO2 /arterial-venous O2 content difference and to find a correlation of the above with lactate clearance in septic shock patients.

MATERIALS AND METHODS:
 
The global hemodynamic, arterial, and central venous blood gas analyses will be simultaneously performed on the T0, T8, T24 (in hours)
The position of the tip of the central venous catheter in the upper part of the right atrium will be confirmed on chest radiograph before sampling
Blood gas samples will be taken anaerobically in 3-mL heparinized syringes and analyzed for blood gas and the same blood gas machines will be used to analyze the arterial and central venous blood gas samples
The pairs of arterial and central venous blood samples were withdrawn simultaneously for determination of the following variables:
PaO2
PaCO2
Central venous oxygen tension (PcvO2)
Central venous carbon dioxide tension (PcvCO2) and SaO2
The Hb and lactate level will be measured from the arterial blood
The arterial oxygen content (CaO2), central venous oxygen content (CvO2), arterio venous oxygen content difference C(a-cv)O2,
veno arterial CO2 tension difference P(cv-a)CO2 ,
P(cv-a)CO2/C(a-cv)O2 ratio, lactate clearance rate (LC)


 Lactate  clearance and survival will be defined as follows:

 CaO2 = (1.34 × SaO2 × Hb) + (0.003 × PaO2)
CvO2 = (1.34 × SvO2 × Hb) + (0.003 × PvO2)
C(a-cv)O2 = CaO2  - CvO2
P(cv-a)CO2 = PvCO2 - PaCO2
P(cv-a)CO2/C(a-cv)O2 ratio = (PcvCO2-PaCO2)/(CaO2 - CvO2) 

LC8 rate = (T0 lactate –T8 lactate)/(T0 lactate) × 100%

LC24 rate = (T0 lactate –T24 lactate)/(T0 lactate) × 100%

LC rate =10%from T0 toT8(hrs)
LCrate= 20%fromT0toT24(hrs)

Lactate clearance and survival will be defined as follows:
CaO2 = (1.34 × SaO2 × Hb) + (0.003 × PaO2) 
CvO2 = (1.34 × SvO2 × Hb) + (0.003 × PvO2)
 C(a-cv)O2 = CaO2 -CvO2
 P(cv-a)CO2 = PvCO2 - PaCO2
P(cv-a)CO2/C(a-cv)O2 ratio = (PvCO2 -PaCO2)/(CaO2 -CvO2) 

LC8 rate = (T0 lactate –T8 lactate)/(T0 lactate) × 100%

LC24 rate = (T0 lactate –T24 lactate)/(T0 lactate) × 100%

LC rate= 10%fromT0 toT8(hrs)

 LCrate= 20%fromT0toT24(hrs)

 4 groups
1.LC 8A (>10%)
2.LC 8B(<10%)
3.LC 24A(>20%)
4.LC 24B(<20%)
 
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