| CTRI Number |
CTRI/2023/06/053815 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO FIND RELATIONSHIP BETWEEN INFERIOR VEIN AND FEMORAL VEIN AND ARTERY IN ASSSESSING THE FLUID STATUS IN CRITICALLY ILL PATIENTS |
|
Scientific Title of Study
|
DIAGNOSTIC ACCURACY OF FVD/FAD RATIO AND IVC FOR PREDICTION OF VOLUME STATUS IN CRITICALLY ILL PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AFZAL AZIM |
| Designation |
PROFESSOR |
| Affiliation |
sanjay gandhi postgraduate institute of medical sciences |
| Address |
CRITICAL CARE MEDICINE,CCM, 1ST FLOOR, SGPGI, New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AFZAL AZIM |
| Designation |
PROFESSOR |
| Affiliation |
sanjay gandhi postgraduate institute of medical sciences |
| Address |
CRITICAL CARE MEDICINE, CCM, 1 ST FLOOR, SGPGI, New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M VINAY KUMAR |
| Designation |
SENIOR RESIDENT |
| Affiliation |
sanjay gandhi postgraduate institute of medical sciences |
| Address |
CRITICAL CARE MEDICINE, CCM, 1ST FLOOR, SGPGI, New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
meruguvinay007@gmail.com |
|
|
Source of Monetary or Material Support
|
| sanjay gandhi postgraduate institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF CRITICAL CARE SGPGI |
| Address |
New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014 |
| 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 AFZAL AZIM |
SGPGI |
CRITICAL CARE DEPARTMENT/CCM/1ST FLOOR/Raibareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
9984988393
draazim2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sanjay gandhi postgraduate institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R579||Shock, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients over 18 years of age on mechanical ventilation on invasive monitoring. |
|
| ExclusionCriteria |
| Details |
1) Patients with a right atrium dilatation or right ventricle tumour.
2) Patients with severe stenosis of the pulmonary valve or tricuspid valve
3) Patients with a skin infection at the puncture site
4) Patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation, lower extremity varicose veins, or aortic stenosis.
5) Patients who IVC cannot be visualized.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the correlation of femoral vein diameter & femoral artery diameter with IVC to central venous pressure measurements & to help ascertain the fluid volume status in a critically ill patient |
first 24 hours of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes |
first 24 hours of admission |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
23/06/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this exploratory study is to find out the correlation of femoral vein diameter (FVD)/femoral artery diameter (FAD) with IVC to central venous pressure (CVP) measurements and to help ascertain the fluid volume status in a critically ill patient and to see whether FVD/FAD ratio be alternative to IVC measurement in assessing volume status in critically ill patients. |