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CTRI Number  CTRI/2024/07/070495 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational 
Study Design  Single Arm Study 
Public Title of Study   USE OF FEMORAL VEIN PULSATILITY TO PREDICT ACUTE KIDNEY INJURY IN PATIENTS WITH COMPLICATED ABDOMINAL INFECTIONS 
Scientific Title of Study   The role of Femoral vein Pulsatility in the prediction of Acute Kidney Injury in patients with peritonitis and Abdominal sepsis: 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  BHAVANA K 
Designation  Senior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no 5011 5 th floor- Administrative block Department of Anaesthesiology,Pain Medicine & Critical care AIIMS-New Delhi

South
DELHI
110029
India 
Phone  9600717490  
Fax    
Email  bhavanakayarat27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Puneet Khanna 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room no 5011, 5 th floor- Administrative block Dept. of Anaesthesiology,Pain Medicine & Critical Care AIIMS- New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query  
Name  BHAVANA K 
Designation  Senior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no 5011, 5 th floor- Administrative block Dept of Anaesthesiology,Pain Medicine & Critical care AIIMS-New Delhi

South
DELHI
110029
India 
Phone  9600717490  
Fax    
Email  bhavanakayarat27@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi 
Address  AIIMS,Ansari Nagar,New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Bhavana K  All India Institute of Medical Sciences, New Delhi  Dept of Anesthesiology,Pain Medicine and Critical Care, AIIMS, Ansari Nagar 110029
South West
DELHI 		 9600717490

bhavanakayarat27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS-New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients, aged 18-65 years diagnosed with complicated intra-abdominal infections and abdominal sepsis (complicated intra-abdominal infections leading to sepsis and septic shock) 
 
ExclusionCriteria 
Details  Patients with inadequate window for USG
Patients in respiratory distress (respiratory rate more than 35/min, accessory muscles of respiration in use)
Patients with Liver cirrhosis
Patients with Portal thrombosis
Patients with Deep vein thrombosis of lower limb
Pregnancy
Patients with Chronic venous limb disease
Patients with Chronic kidney disease
Patients with AKI on admission
Patients with Unilateral nephrectomy
Patients who have undergone Renal transplant
Patients with Unilateral or bilateral hydronephrosis
Patients with Renal malignancies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of acute kidney injury   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Association between serial femoral vein doppler measurements (Day 1, Day 3 and Day5) and development of acute kidney injury within 7 days of admission
2. Association between serial femoral vein doppler measurements (Day 1, Day 3 and Day5) and MAKE-30 (Major Adverse Kidney Events within 30 days)
 		 Day 1, Day 3 and Day 7 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   22/07/2024 
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="2"
Months="0"
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   At the bedside, in patients with poorly accessible thoracic and abdominal wall examination after sternotomy, thoracotomy, or laparotomy; transthoracic echocardiographic (TTE) and VEXUS examinations might be challenging because of suboptimal echogenicity, due to unfavourable anatomy and sometimes, positive pressure ventilation. In such patients, the femoral vein Doppler ultrasound examination is feasible and has correlated well with venous congestion in the critically ill population. The study aims to determine the association between the presence of a pulsatile femoral vein and acute kidney injury in patients with complicated intra-abdominal infections and abdominal sepsis.
Baseline demographic details will be obtained from medical records. The patients will be evaluated at baseline (within 24 hours of admission to ICU: Day 1 ), on Day 3( within 72 hrs of admission) and on Day 5. For each time point, the hemodynamic, respiratory and cardiac ultrasound parameters will be noted.USG examination for femoral vein pulsatility will be done by a trained intensivist with more than 5 years’ of experience in bedside ultrasound. All images will be reviewed and confirmed by another intensivist with extensive bedside ultrasound experience.
Measurement of Femoral Vein Pulsatility: Ultrasound assessment will be performed bedside in the supine position using a linear array probe. Common femoral vein will be identified 2–3 cm below the inguinal ligament and it will be examined in both short and long axis with angle correction within 60°. Normal Femoral Vein Doppler (FVD) will be defined as antegrade mildly pulsatile uninterrupted pattern with respiratory variation and retrograde flow of less than 1/3rd of antegrade flow. FVD will be considered significant or suggestive of venous congestion if either of the criteria  is fulfilled. Pulsatile in nature 2. Retrograde flow velocity of more than 10 cm/s 3. Retrograde flow velocity is more than 1/3rd of antegrade flow velocity (flow reversal) 
Outcome measures: The value for baseline serum creatinine will be determined in a hierarchical approach. The lowest serum creatinine between 12 months and 24 h before hospital admission will be used when available. If no such creatinine value is available, the lowest creatinine value between 24 hours prior to hospital admission and the time of ICU admission will be used. 

 
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