| CTRI Number |
CTRI/2021/11/038170 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in arterial and end tidal carbon dioxide levels before and after fluid resuscitation in septic shock patients admitted in ICU |
|
Scientific Title of Study
|
Arterial carbon dioxide and end-tidal carbon dioxide changes in pre and post volume resuscitation patients with septic shock admitted in Intensive Care Unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Kant Dogra |
| Designation |
DM Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia and Intensive Care, Nehru Block, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9418465978 |
| Fax |
|
| Email |
drravikantdogra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Podder |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and Intensive Care, Nehru Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009526 |
| Fax |
|
| Email |
podder_s@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Podder |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and Intensive Care, Nehru Block, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009526 |
| Fax |
|
| Email |
podder_s@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector-12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ravi Kant Dogra |
PGIMER, Chandigarh |
Main ICU, Level II, Department of Anesthesia and Intensive Care, Nehru Block, PGIMER
Chandigarh
CHANDIGARH |
9418465978
drravikantdogra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all patients with age > 18 years admitted in intensive care unit with septic shock. |
|
| ExclusionCriteria |
| Details |
patients who refuse to participate in the study and patients having conditions affecting lung permeability like interstitial lung disease, idiopathic pulmonary fibrosis, severe bronchial asthma ,COPD, or cardiovascular conditions like congenital heart disease, valvular heart disease, cardiomyopathy having baseline LVEF< 30% , h/o pulmonary embolism, bronchopleural fistula, extracorporeal life support. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in arterial PCO2 and end- tidal carbon dioxide (EtCO2) pre and post resuscitation in septic shock patients |
At 0 hour, 1 hour and 6 hours of resuscitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation between central venous-arterial PCO2 (∆PCO2) gap and arterial PCO2-EtCO2 (A-E) CO2 gap in all the patients |
At 0 hour, 1 hour and 6 hours of resuscitation |
correlation between these two gaps in critically ill septicemic patients in the context of extent of fluid requirement, extent of inotrope requirement, extent of organ damage (SOFA score) and ICU mortality
|
at the time of admission and discharge/death |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/11/2021 |
| 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="0"
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
|
The primary purpose of the study is to determine changes in arterial PCO2 and end-tidal carbon dioxide pre and post resuscitation in septic shock patients admitted in ICU. The hypothesis is that the arterial PCO2 and EtCO2 change after volume resuscitation with changes in the gap between the two. |