| CTRI Number |
CTRI/2024/12/077833 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of requirement of fluid in sick patients with sepsis by echocardiographic measurements of the aorta |
|
Scientific Title of Study
|
Velocity- time integral and stroke volume measured in the ascending aorta for prediction of volume responsiveness in mechanically ventilated adults with septic shock |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4th floor, portable cabin, room no 14, Teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4th floor, portable cabin, room no 14, Teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4th floor, portable cabin, room no 14, Teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sulagna Bhattacharjee |
| Address |
4th floor, portable cabin, room no 14, Teaching block, AIIMS, New Delhi |
| Type of Sponsor |
Other [] |
|
|
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 Sulagna Bhattacharjee |
Medical & Surgical ICU, AIIMS, New Delhi |
Main Block & Surgical block, AIIMS, Ansari Nagar
South
DELHI |
9818212531
bhattacharjee.sulagna85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
| InstituteEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
adult patients of either sex, admitted to the adult intensive care unit, intubated and mechanically ventilated, with sepsis, requiring vasopressor therapy (noradrenaline infusion). |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate
2.Pregnancy
3.BMI less 18 or more than 30 kg/m2
4.Patients with known aortic valve diseases, aortic aneurysm, aortic atherosclerosis.
5.Any contraindication to passive leg raising maneuver |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify diagnostic accuracy of change in aortic velocity time integral to predict volume responsiveness |
3 days (72 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlation between LVOT VTI & Ao VTI.
2. Correlation between SV measured from LVOT & aorta. |
During assessment of fluid responsiveness in patients with septic shock |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
20/12/2024 |
| 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)
Modification(s)
|
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
|
This observational study recruiting 53 patients will help in assessment of the usefulness of aortic echocardiography in diagnosing volume responsiveness. |