| CTRI Number |
CTRI/2024/12/078792 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the usefulness of measuring blood flow time in the femoral artery for deciding the need of fluid therapy in adult patients with septic shock |
|
Scientific Title of Study
|
Validation of pressure transducer derived femoral artery corrected flow time for volume responsiveness in adult patients with 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 |
Dr Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 5011, 5th floor, Teaching block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 5011, 5th floor, Teaching block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 5011, 5th floor, Teaching block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room no 5011, 5th Floor, Teaching block, AIIMS, New Delhi-110029 |
| 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 |
| DrSulagnaBhattacharjee |
AB8 ICU & Surgical ICU, AIIMS, New Delhi |
AB8, 8th floor Main block, & Surgical Icu, Surgery block, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI |
9818212531
bhattacharjee.sulagna85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of septic shock, with femoral arterial catheter and central venous catheter inserted for hemodynamic management and monitoring |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the diagnostic ability femoral artery corrected flow time to predict volume responsiveness defined by an increase in cardiac output by more than 10% with passive leg raise test
|
within first 72 hours of developing septic shock |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To develop a predictive equation to estimate cardiac output from corrected flow time and other hemodynamic data.
2. To know the diagnostic ability of change in femoral artery corrected flow time after passive leg raise to predict volume responsiveness. |
within first 72 hours of developing septic shock |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/01/2025 |
| 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)
|
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 is a prospective observational study, involving 30 adult critically ill patients, to know the predictive ability of femoral artery corrected flow time, a parameter derived from the femoral artery waveform, in assessing fluid responsiveness in patients with septic shock. |