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CTRI Number  CTRI/2025/07/091812 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Evaluation of Serial VExUS score for predicting AKI in post-operative peritonitis patients. 
Scientific Title of Study   EVALUATION OF SERIAL VENOUS EXCESS ULTRASOUND SCORE(VExUS) FOR PREDICTING ONSET OF ACUTE KIDNEY INJURY IN POST- OPERATIVE PERITONITIS PATIENTS 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aman Rai 
Designation  Post Graduate Resident  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9643838037  
Fax    
Email  raiaman17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neerja Banerjee 
Designation  Professor and Head of Department  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9810517575  
Fax    
Email  neerja.banerjee@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neerja Banerjee 
Designation  Professor and Head of Department  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi Central DELHI 110001 India

Central
DELHI
110001
India 
Phone  9810517575  
Fax    
Email  neerja.banerjee@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001, Central Delhi 
 
Primary Sponsor  
Name  NIL  
Address  Nil  
Type of Sponsor  Other [Nil] 
 
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 
Aman Rai  ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001
Central
DELHI 		 9643838037

raiaman17@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS and Dr. RML Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 to 65 years with post operative peritonitis
2. ASA grade I-II
3.On USG assesment IVC diameter greater than 2cm. 
 
ExclusionCriteria 
Details  1. Expected ICU stay duration less than 24hours.
2.Known Cardiac or Liver or Lung disease.
3.Preexisting AKI or CKD
4.Pancreatitis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate serial Venous Excess Ultrasound Score(VExUS)for predicting onset of Acute Kidney Injury in post-operative peritonitis patients.  0 day followed by 24 hourly till day 6 of ICU admission. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate serial VExUS scoring with mechanical ventilation duration.
2. To correlate serial VExUS scoring with 30 day mortality. 		 0 day followed by 24 hourly till day 6 of ICU admission 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   07/08/2025 
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="5"
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 will be conducted after obtaining approval from the Institutional Ethics Committee. Patients meeting the inclusion and exclusion criteria will be enrolled after written informed consent is obtained from the patient or their legally authorized representative.

All enrolled patients will receive standard ICU care. At ICU admission, baseline clinical and physiological data including patient demographics, BMI, diagnosis, APACHE II score, qSOFA score, hemodynamic parameters, and vasopressor use will be recorded.

A 2D echocardiogram will be performed to exclude cardiac causes of venous congestion. Bedside ultrasound assessments will be conducted using a curvilinear probe (1–5 MHz) by an anesthesiologist with at least 3 years of ultrasound experience. Patients will be assessed in the supine position.

The Venous Excess Ultrasound Score (VExUS) will be recorded at ICU admission (0 hours) and then every 24 hours for up to 6 days or until the development of Acute Kidney Injury (AKI), whichever occurs earlier. AKI will be diagnosed and staged according to KDIGO criteria, based on changes in serum creatinine and/or urine output.

VExUS Scoring Protocol:

1. Inferior Vena Cava (IVC) Assessment:

Measured in both long and short axes at the intrahepatic segment.

Graded based on diameter and respiratory variation:

Grade 0: <5 mm with respiratory variation

Grade I: 5–9 mm with respiratory variation

Grade II: 10–19 mm with respiratory variation

Grade III: >20 mm with respiratory variation

Grade IV: >20 mm with minimal or no respiratory variation




2. Hepatic Vein (HV) Doppler:

Pulsed-wave Doppler of the middle or right hepatic vein.

Graded based on S and D wave morphology:

Grade 0: Normal (S > D)

Grade I: S < D with antegrade S wave

Grade III: S wave flat/inverted or biphasic trace




3. Portal Vein (PV) Doppler:

Assessed via lateral abdominal approach.

Pulsatility Index (PI) calculated as:


Grading:

Grade 0: PI < 0.3

Grade I: PI 0.3–0.49

Grade III: PI 0.5–1.0




4. VExUS Composite Score:

Grade 0: IVC < Grade III, HV Grade 0, PV Grade 0

Grade I: IVC Grade IV with normal HV/PV

Grade II: IVC Grade IV with mild abnormalities in HV/PV

Grade III: IVC Grade IV with severe abnormalities in HV and/or PV




In addition to VExUS, serum urea and creatinine levels will be monitored daily. The total duration of mechanical ventilation and 30-day mortality outcomes will also be recorded.


 
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