| CTRI Number |
CTRI/2025/07/090007 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study assessing vena caval congestion using ultrasound in critically ill ICU patients |
|
Scientific Title of Study
|
Evaluation of Vena Cava Ultrasound for Predicting Venous Congestion in Critically Ill Patients: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lutfur rahman |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Guwahati |
| Address |
Departmrnt of Anaesthesiology Pain medicine and critical care medicine AIIMS Guwahati
changsari kamrup ASSAm
Kamrup ASSAM 781101 India |
| Phone |
7636900248 |
| Fax |
|
| Email |
lutfurrahman9990@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anirban Bhattacharjee |
| Designation |
Assitant professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Departmrnt of Anaesthesiology Pain medicine and critical care medicine AIIMS Guwahati
changsari kamrup ASSAm
Kamrup ASSAM 781101 India |
| Phone |
8014076629 |
| Fax |
|
| Email |
anirbanbhattacharjee@aiimsguwahati.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Anirban Bhattacharjee |
| Designation |
Assitant professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Departmrnt of Anaesthesiology Pain medicine and critical care medicine AIIMS Guwahati
changsari kamrup ASSAm
ASSAM 781101 India |
| Phone |
8014076629 |
| Fax |
|
| Email |
anirbanbhattacharjee@aiimsguwahati.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Departmrnt of Anaesthesiology Pain medicine and critical care medicine AIIMS Guwahati
changsari kamrup ASSAm |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Lutfur rahman |
AIIMS Guwahati |
2 nd floor
department of Anaesthesiology Pain Medicine critical care medicine AIIMS Guwahati Kamrup ASSAM |
07636900248
lutfurrahman9990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I878||Other specified disorders of veins, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 years or older who are admitted to the ICU invasively ventilated and expected to stay for at least 48 hours will be eligible for inclusion |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they are pregnant have known anatomical anomalies or obstruction of the IVC present with unreliable IVC windows on ultrasound liver cirrhosis or if consent is refused |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of interest is venous congestion defined as presence of mild congestion in atleast one of the hepatic portal and renal doppler assessments |
5days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of interest is venous congestion defined as presence of mild congestion in atleast one of the hepatic, portal and renal doppler assessments. |
5days |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
15/07/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 prospective observational study aims to evaluate the utility of vena cava ultrasound in predicting systemic venous congestion in critically ill invasively ventilated patients admitted to a mixed medical-surgical ICU Traditional markers like central venous pressure have limitations and while the VEXUS (Venous Excess Ultrasound) grading system has shown promise in cardiac surgical patients its applicability in non-cardiac ICU patients remains unclear
The primary objective is to assess the predictive ability of the maximum anteroposterior diameter of the inferior vena cava (IVCAP) for venous congestion, defined by at least mild abnormalities in hepatic portal or renal venous Doppler Secondary objectives include comparing diagnostic accuracy between IVCAP lateral diameter IVCLat their ratio IVCAP Lat and IVC distensibility index along with evaluating their correlation with acute kidney injury AKI
Adult patients m ore than18 years expected to remain ventilated for more than 48 hours will undergo serial ultrasound evaluations over 5 days Venous Doppler studies and IVC measurements will be performed with standardized protocols using B-mode and Doppler imaging AKI will be assessed as per KDIGO criteria and correlated with ultrasound findings using logistic regression and ROC analysis
The study will enroll 64 patients as determined by sample size calculations based on expected AUC values Results aim to establish optimal IVC diameter cutoffs and validate vena cava ultrasound as a non-invasive diagnostic tool for venous congestion and its association with AKI in the ICU setting |