| CTRI Number |
CTRI/2024/05/068061 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of pCO2 gap in prediction of clinical outcome of patients in septic shock. |
|
Scientific Title of Study
|
Role of central venous-arterial pCO2 difference(pCO2 gap) in prediction of clinical outcome and prognosis of patients in septic shock. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navneet Singh |
| Designation |
Resident Anaesthesiology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Anaesthesiology and Critical Care, Command Hospital Air Force Bangalore, HAL Old Airport Road, Agram Post, Bengaluru-560007
Bangalore
KARNATAKA
560007
India |
| Phone |
6302821448 |
| Fax |
|
| Email |
navneet.55singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Sapra |
| Designation |
Head of the Department |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Anaesthesiology and Critical Care, Command Hospital Air Force Bangalore, HAL Old Airport Road, Agram Post, Bengaluru-560007
Bangalore
KARNATAKA
560007
India |
| Phone |
8197084270 |
| Fax |
|
| Email |
adityasapra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Paridhi S Gupta |
| Designation |
Senior Resident |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Anaesthesiology and Critical Care, Command Hospital Air Force Bangalore, HAL Old Airport Road, Agram Post, Bengaluru-560007
Bangalore
KARNATAKA
560007
India |
| Phone |
9407500837 |
| Fax |
|
| Email |
paridhis1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology and Critical Care, Command Hospital Air Force Bangalore, HAL Old Airport Road, Agram Post, Bengaluru-560007, India. |
|
|
Primary Sponsor
|
| Name |
Navneet Singh |
| Address |
Dept of Anaesthesiology and Critical Care, Command Hospital Air Force Bangalore, HAL Old Airport Road, Agram Post, Bengaluru-560007, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Navneet Singh |
Command Hospital Air Force Bangalore |
Dept of Anaesthesiology and Critical Care
Bangalore
KARNATAKA |
6302821448
navneet.55singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Command Hospital Air Force Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients admitted as a case of Septic Shock with Vasopressor requirement to maintain Mean Arterial Pressure greater than 65mmHg, Serum Lactate level above 2mmol/L and without any hypovolemia. |
|
| ExclusionCriteria |
| Details |
Pregnancy, age below 18yrs, patients with end stage neoplasms, and patients suffering from lung diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 28 day mortality rate |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of stay in ICU, SOFA score, and Serum Lactate levels |
28 days |
|
|
Target Sample Size
|
Total Sample Size="101"
Sample Size from India="101"
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
26/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A prospective observational study will be conducted in a 17 bedded ICU setup of a Multispecialty, University affiliated hospital. A written and informed consent will be taken from the patients/their next of kin(NOK), meeting the inclusion criteria of the study. ABG and VBG samples will be taken for patients diagnosed to be in septic shock, through central venous catheter and arterial catheter respectively. The samples will be taken at T= 0 Hrs and T= 6 Hrs, where T0 is the time at which the patient was started on vasopressor support. PCO2 gap found (the worse value among T0 and T6) will be considered and correlated with 28 day mortality rates of the patients. Similarly PCO2 values will also be correlated with : Serum Lactate levels, SOFA score and Length of stay in ICU Positive correlation will be considered if there are higher 28 day mortality rates with ð›¥PCO2 > 6mmHg. |