| CTRI Number |
CTRI/2021/02/031158 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study Correlation Of Two Blood Gas Analysis Derived Parameters, Veno-Arterial Carbon Dioxide Pressure Difference To Arterio-Venous Oxygen Content Difference Ratio With Lactate Clearance Rate During Early Resuscitation In Septic Shock Patients |
|
Scientific Title of Study
|
Correlation Of Veno-Arterial Carbon Dioxide Pressure Difference To Arterio-Venous Oxygen Content Difference Ratio With Lactate Clearance Rate For Early Resuscitation Goal In Patients Of 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 DEEPEISH GUPTA |
| Designation |
DrNB SUPERSPECIALITY SENIOR RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING, SECOND FLOOR, DEPARTMENT OF CRITICAL CARE MEDICINE, ABVIMS & DR RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
dr.deepeish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPEISH GUPTA |
| Designation |
DrNB SUPERSPECIALITY SENIOR RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING, SECOND FLOOR, DEPARTMENT OF CRITICAL CARE MEDICINE, ABVIMS & DR RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
dr.deepeish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPEISH GUPTA |
| Designation |
DrNB SUPERSPECIALITY SENIOR RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING, SECOND FLOOR, DEPARTMENT OF CRITICAL CARE MEDICINE, ABVIMS & DR RML HOSPITAL, BABA KHARAK SINGH MARG, CONNAUGHT PLACE
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
dr.deepeish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABVIMS DR RAM MANOHAR LOHIA HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING, SECOND FLOOR, DEPARTMENT OF CRITICAL CARE MEDICINE, ABVIMS & DR RML HOSPITAL, BABA KHARAG SINGH MARG, CONNAUGHT PLACE, NEW DELHI 110001 |
| 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 SEEMA BALKRISHNA WASNIK |
DR SEEMA BALKRISHNA WASNIK |
ROOM NO 202, TRAUMA BUILDING, SECOND FLOOR, DEPARTMENT OF CRITICAL CARE MEDICINE, ABVIMS & DR RML HOSPITAL, BABA KHARAG SINGH MARG, CONNAUGHT PLACE, NEW DELHI 110001
Central
DELHI |
01123404699
wasnikseema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL ETHICAL COMMITEE ABVIMS & DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B948||Sequelae of other specified infectious and parasitic diseases. Ayurveda Condition: AUPASARGIKA-TRUSHNA, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
> 18 yrs Admitted in ICU for more than 24 hrs for both medical or surgical disease with
septic shock |
|
| ExclusionCriteria |
| Details |
1 Refusal of Consent
2 Drop out during sampling period
3 Pregnant females
4 Liver Cirrhosis child Pugh C
5 End stage renal disease
6 Sustained hemodynamic unstable Cardiac arrhythmias or LVEF < 35%
7 Severe COPD (grade 3&4) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine correlation between Veno-arterial carbon dioxide pressure difference to arterio-venous oxygen content difference (Pcv-aCo2/Ca-cvO2) ratio and lactate clearance
rate (T24) for early resuscitation goal in septic shock patients |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine Correlation between Pcv-aCo2/Ca-cvO2 ratios (T24) with lactate
levels, Scvo2, Pv-aCo2 clearance
2. To determine ability of Pcv-aCo2/Ca-cvO2 ratio (T24) to predict 28 days mortality
and organ dysfunction using SOFA score at day 3
3. To determine incidence of 28 day mortality |
28 days |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
11/02/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Prospective Observational Cohort Study to be carried out to find correlation of Veno-arterial carbon dioxide pressure difference to Arterio-venous content difference ratio with lactate clearance rate for early resuscitation goal in septic shock patients admitted for more than 24 hrs in mixed surgical & medicine ICU in 55 patients of age more than 18 yrs of either sex. |