| CTRI Number |
CTRI/2017/11/010434 [Registered on: 09/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Parallel group single observation |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To assess the efficacy of Echocardiographic parameter and carotid artery ultrasonosonography parameter to predict which patient need intravenous fluid in ICU |
|
Scientific Title of Study
|
Efficacy of left ventricular outflow tract velocity time integral (LVOT-VTI) and carotid artery velocity time integral (CA-VTI) as predictors of fluid responsiveness in patients with sepsis and septic shock |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No secondary ID |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dalim Kumar Baidya |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care,
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dalim Kumar Baidya |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care,
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Chawhan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care,
AIIMS
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
gani6837@gmail.com |
|
|
Source of Monetary or Material Support
|
| Non-funded study conducted in AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
New Delhi - 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dalim Kumar Baidya |
All India Institute of Medical Sciences New Delhi |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi -110029
South
DELHI |
9868398013
dalimkumar.ab8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ICU patients on mechanical ventilation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
No specific comparator agent. It is an observational study where cardiac echocardiography parameter will be compared with carotid artery USG parameter |
| Intervention |
Nil |
No specific intervention - only echocardiographic observation done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
mechanically ventilated adult patients (aged between 18-65 years. |
|
| ExclusionCriteria |
| Details |
1. BMI>30 Kg/m2.
2. Patients in whom PLR test cannot be performed (eg.raised ICP, intracranial space occupying lesions).
3. Patients with valvular heart diseases.
4. Patients with cardiomyopathy.
5. Patients having carotid artery stenosis.
6. Patients with pelvic and lower limb fractures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of change in-left ventricular outflow tract velocity time integral (LVOT-VTI) and change in carotid artery velocity time integral (CA-VTI) |
at the time of echocardiography - i.e., at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of delta LVOT VTI, delta SV and delta CA –VTI
And
Determine sensitivity, specificity and area under ROC curve of LVOT VTI and carotid VTI |
at the time of echocardiography - i.e., at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
31/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Post graduate thesis submitted; but not yet published in any journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We did a prospective parallel group observational study
to assess efficacy of delta CA-VTI in predicting fluid responsiveness and its
correlation with delta LVOT-VTI in critically patients on mechanical
ventilation in sepsis, septic shock and those not in sepsis in a mixed
medical-surgical ICU.
To conclude, CA-VTI can be a useful dynamic variable to
assess fluid responsiveness in critically ill patients on mechanical
ventilation in sepsis and those not in sepsis and it correlates well with
similar changes in LVOT-VTI and stroke volume in these patient population.
However, in the more important subset of patient population with septic shock,
usefulness of CA-VTI remains questionable. Further study with larger sample
size requires to be done to address this issue.
|