| CTRI Number |
CTRI/2024/09/073620 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How the Central Venous to Arterial Carbon Dioxide Gradient Affects Sepsis Outcomes |
|
Scientific Title of Study
|
Role of Central Venous to Arterial
Carbon Dioxide Gradient in Outcomes of
Sepsis |
| Trial Acronym |
SepsisCO2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samruddhi Chougale |
| Designation |
Senior Resident |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak
Santosh Niwas, Plot no. 29/30, H. No 962/10, Galli no 8, Adarshnagar, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9763181707 |
| Fax |
|
| Email |
samru.c1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dhruva Chaudhry |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak
Santosh Niwas, Plot no. 29/30, H. No 962/10, Galli no 8, Adarshnagar, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9763181707 |
| Fax |
|
| Email |
dhruvachaudhry@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Samruddhi Chougale |
| Designation |
Senior Resident |
| Affiliation |
Pandit B.D Sharma, PGIMS, Rohtak |
| Address |
Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak
Santosh Niwas, Plot no. 29/30, H. No 962/10, Galli no 8, Adarshnagar, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9763181707 |
| Fax |
|
| Email |
samru.c1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak, Haryana, 124001 |
|
|
Primary Sponsor
|
| Name |
Dr Dhruva Chaudhry |
| Address |
Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak, Haryana, 124001 |
| 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 Samruddhi Chougale |
PGIMS, Rohtak |
Department of Pulmonary and Critical Care Medicine, PGIMS, Rohtak, Haryana, 124001
Rohtak
HARYANA |
9763181707
samru.c1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pandit.B.D.Sharma PGIMS/UHS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 18years.
2. Diagnosis of sepsis with predefined criteria.
3. Admitted in ICU/ high dependency unit (HDU). |
|
| ExclusionCriteria |
| Details |
1. Acute Exacerbation COPD.
2. Any chronic respiratory illness with pCO 2 more than 50mm Hg.
3. Liver dysfunction defined as encephalopathy and impaired synthetic function
(international normalized ratio [INR] of ≥1.5) 22 , a patient with cirrhosis or pre-existing
liver disease.
4. Pregnant female.
5. End stage malignancy cases or cases admitted with treatment related complications.
6. Do not resuscitate orders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of Central venous to arterial carbon dioxide gradient in predicting sepsis outcomes |
Time at which patient gets discharged from the ICU or died in the ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in ΔpCO2 from 0 to 2 hours & association with sepsis outcomes. |
Time at which patient gets discharged from the ICU or died in the ICU |
Change in ΔpCO 2 from 0 to 6 hours & association with sepsis outcomes.
|
Time at which patient gets discharged from the ICU or died in the ICU |
Change in ΔpCO 2 & association with lactate clearance.
|
Time at which patient gets discharged from the ICU or died in the ICU |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
18/09/2024 |
| 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="1"
Months="4"
Days="10" |
|
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
|
Sepsis
is a heterogeneous and complex syndrome, characterized by a dysregulated host
response to infection which can be life-threatening.
• The
major causes of admission to Intensive Care Units (ICUs)
• Mortality rate ranges from 25-50%.
• The
association of lactate level with mortality in patients with suspected
infection and sepsis is well established.
• ΔpCO2
reflects the difference in partial pressure of carbon dioxide (pCO2)
between central venous blood and arterial blood.
• It
has been proposed as an indicator of tissue perfusion and may offer insights
into sepsis severity.
• While
it is not a direct measure of oxygen delivery, ΔpCO2 can provide
valuable information about the adequacy of tissue perfusion and the presence of
global tissue hypoxia.
• This
study aimed to determine the change in central venous and arterial pCO2 difference
(ΔpCO2 ) at 0 and 6 hours to predict outcome in sepsis
patients. This can act as an alternative marker to lactate clearance. |