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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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