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CTRI Number  CTRI/2024/04/065711 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   carbon di oxide gap in arterial and venous sample as a guide to adequacy of fluid resuscitation in postoperative surgical patients and prediction of prognosis 
Scientific Title of Study   pCO 2 gap (central venous-arterial carbon dioxide difference) as a guide to adequacy of fluid resuscitation in postoperative high risk surgical patients and prediction of prognosis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amandeep Kaur 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Departmant of Critical Care Medicine Fourth Floor Room No. 11 ICU Block Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana 141001

Ludhiana
PUNJAB
141001
India 
Phone  9779656700  
Fax    
Email  vikramandeep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amandeep Kaur 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Departmant of Critical Care Medicine Fourth Floor Room No. 11 ICU Block Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana 141001


PUNJAB
141001
India 
Phone  9779656700  
Fax    
Email  vikramandeep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amandeep Kaur 
Designation  Associate Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Departmant of Critical Care Medicine Fourth Floor Room No. 11 ICU Block Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana 141001


PUNJAB
141001
India 
Phone  9779656700  
Fax    
Email  vikramandeep@gmail.com  
 
Source of Monetary or Material Support  
Department of Critical Care Medicine 4TH floor ICU Block Dayanand Medical College and Hospital, Ludhiana Punjab India 141001  
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Civil Lines Tagore Nagar Ludhiana Punjab India 141001 
Type of Sponsor  Private medical college 
 
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 Amandeep Kaur  Dayanand Medical College & Hospital, Ludhiana  Dr Amandeep Kaur dept of Critical Care Medicine ICU block 4th floor Dayanand Medical College and Hospital civil lines Tagore Nagar Ludhiana
Ludhiana
PUNJAB 
9779656700

vikramandeep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K650||Generalized (acute) peritonitis, (3) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (4) ICD-10 Condition: K868||Other specified diseases of pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Postoperative high risk surgical patients- All patients undergoing abdominal or
vascular surgery will be included if they have one of the following criteria: 1) one
demographic criterion and one surgical criterion; 2) three or more demographic
criteria; 3) one or more surgical criteria; 4) one intensive care criterion. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic stability

Organ failure


 
12 and 24 hours


 
 
Secondary Outcome  
Outcome  TimePoints 
length of ICU stay
mortality 
at ICU discharge
28 day  
 
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)   21/04/2024 
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="0"
Months="6"
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  
BACKGOUND
The high mortality due to circulatory shock necessitate the need for early biomarkers to assess
tissue perfusion which could provide important information about prognosis and help guide
resuscitation efforts. The PCO 2  gap is difference between partial pressure of CO 2  in venous blood
(PvCO 2 ) and arterial blood (PaCO2)as blood lactate and venous oxygen saturation (SvO2) are
commonly used but it has many limitations .Raised pCO2 gap has been recognized as a marker
of poor outcome during circulatory shock and it should therefore be part of our clinical
evaluation to guide fluid administration in the early phases of resuscitation. An increase in
pCO2 gap(PcvCO2- PaCO2) >6mm of Hg suggests a shock that may be responsive to fluid
resuscitation. We aim to calculate pCO2 gap in postoperative high risk patients as it will aide as
a guide to adequacy of resuscitation and outcome of such patients.
Aims and objectives
Primary objective
1.To access the correlation of pCO 2 with adequacy of fluid resuscitation in postoperative high
risk surgical patients
2. To access correlation of pCO 2 gap (central venous-arterial carbon dioxide difference) with
fluid resuscitation in postoperative high risk surgical patients
Secondary objectives
1. Comparing pCO2 gap with serum lactate levels, SvO2 levels
2. Correlation of pCO 2 with 28 day mortality in postoperative high risk surgical patients
Patients and Methods

In post operative period following high risk surgery, patients who are in shock and mechanical
ventilation, arterial blood gas will be done to evaluate pCO 2 , lactate, pO 2 , and simultaneous
central venous sample to evaluate the same will be done at onset of shock, following fluid
resuscitation, 2hrs, 6 hrs, 24 hours. The PCO 2 gap will be calculated by the difference between
central venous partial pressure of carbon dioxide and arterial partial pressure of carbon dioxide. ,
routine laboratory tests were obtained by intermittent blood sampling immediately after
admission At ICU admission, data on demographics (age, sex, weight), type of surgical
procedure, Simplified Acute Physiology Score (SAPS) II, and inotropic support will be recorded
in all patients. The study population will be divided into two groups according to fluid
responsiveness. The pCO2, Central and arterial CO2 gaps, SVO2 and lactate level will be
accessed pre and post fluid resuscitation. Postoperative complications will be defined in
accordance with defined criteria until hospital discharge or death as follows: postoperative sepsis
(pneumonia, intraperitoneal abscess, wound infection, peritonitis and urinary tract infection),
acute renal and cardiac failures, postoperative hemorrhage, ischemic events, and postoperative
mortality. Patients will be followed up till hospital discharge or death.
 
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