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CTRI Number  CTRI/2024/10/074890 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 20/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   The Impact of Cumulative Fluid Balance and its clinical outcomes in critically ill adult patients assessed ultrasound scan of intrabdominal veins 
Scientific Title of Study   Cumulative Fluid Balance assessed by Venous Excess Ultrasound (VExUS) scan and its impact on clinical outcomes in Critically Ill Adults: 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  Dr Madivanan M 
Designation  DM Critical Care 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 
Address  Department OF Anesthesiology and critical care, second floor, Institute block, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8870194966  
Fax    
Email  madisaran22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Kumar Mishra 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 
Address  Department OF Anesthesiology and critical care, second floor, Institute block, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9344668104  
Fax    
Email  jipmermishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Senthilnathan Muthapillai 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry 
Address  Department OF Anesthesiology and critical care, second floor, Institute block, Gorimedu, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry -605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Gorimedu, Pondicherry - 605006 India 
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 
Dr Madivanan M  Jawaharlal Institute of Postgraduate Medical Education and Research  Critical care unit, Department of Anesthesiology and Critical care, second floor, Institute block, Gorimedu, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry -605006, India
Pondicherry
PONDICHERRY 
8870194966

madisaran22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Observational Studies, JIPMER, PONDICHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I998||Other disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Critically ill adult patients ( Critically ill patients have been defined as severe respiratory, cardiovascular or neurological derangement often in combination, reflected in abnormal physiological observations and objectively can be defined as patients who have a change in Sequential Organ Failure Assessment (SOFA) score more than 2 from baseline is considered critically ill)
 
 
ExclusionCriteria 
Details  Pregnancy
Severe Tricuspid Regurgitation
Cirrhosis of Liver
Chronic Kidney disease
Patient already on renal replacement therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To detect the correlation between VExUS score and Cumulative fluid balance in critically ill patients at 7 days  To detect the correlation between VExUS score and Cumulative fluid balance in critically ill patients at 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the prevalence of intra-abdominal venous congestion as assessed by VExUS score in critically ill adults
2. To determine the number of mechanical ventilation free days in these patients
3. To study the relationship between severity of intra-abdominal venous congestion and development of Acute Kidney Injury ( AKI)
4. To study the relationship between severity of intra-abdominal venous congestion and need for renal replacement therapy
5. To study the relationship between severity of intra-abdominal venous congestion and ICU length of stay 
ICU length of stay 
 
Target Sample Size   Total Sample Size="227"
Sample Size from India="227" 
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)   25/10/2024 
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 Applicable 
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   After obtaining approval from the Department Postgraduate Research monitoring committee, Institute ethics committee and completing CTRI registration, patients satisfying eligibility criteria will be enrolled in the study. After obtaining informed written consent from the legally acceptable representative (LAR) the patient will be enrolled. The detailed history and demographic details (age, sex, height, weight, BMI and comorbidities) along with baseline vitals, baseline investigations (Urea, Creatinine, total protein, albumin, bilirubin, Hb, platelet count, TLC), echocardiography(velocity time integral, TAPSE, Ejection fraction), sequential organ failure assessment (SOFA) score and clinical diagnosis will be noted. Cumulative fluid balance will be recorded for 7 days after ICU admission. Fluid balance consists of fluid input including both enteral, parenteral intake and fluid output includes urine output, drainage fluid will be calculated daily from day zero of ICU admission to 7 days. At time of ICU admission, at 72 hours and at 7 days of admission venous excess ultrasonography (VExUS) scan will be performed for IVC and abnormal ultrasonography of hepatic vein (HV), portal vein (PV) and intrarenal veins (RV). An intensivist who has performed at least 25 VExUS scans and graded the intra-abdominal venous congestion that has been counterchecked by a radiologist will scan the participants in this study to obtain the VExUS scores.

Ultrasonographic Assessment of HV, PV and RV:

Ultrasound assessment will be performed at the bedside using a phased array probe of 2-5 MHz.. The transducer will be placed at the level of xiphisternum in the craniocaudal direction. The maximum diameter of the IVC is found and measured at the hepatic vein exit. IVC size of >2 cm will be considered as having venous congestion and size of <2 cm will be considered as normal.

Acquisition of Hepatic Vein (HV) window: The transducer is placed in the mid axillary line and the liver is located trying to insonate the hepatic veins in its drainage towards the inferior vena cava. The hepatic veins will be acquired and color flow doppler (BLUE color) will be placed over the hepatic veins as they enter the IVC. The pulse wave doppler cursor will be activated on a hepatic vein prior to it entering the IVC and pulse wave doppler will be initiated. Interrogation by pulsed wave doppler identification and analysis of A, S, and D waves:

1)      S > D = Normal pattern

2)      S < D with antegrade S = Mild abnormality pattern

3)      S flat or inverted or biphasic trace = Severe abnormality pattern

 

Acquisition of Portal Vein (PV) window: A 2-D image of the Portal Vein will be acquired, and color flow Doppler RED flow (towards the probe) will be placed. The pulse wave Doppler will be performed on the Portal Vein.

Interpretation of PV Doppler study: Pulsatility index is calculated as (Vmax  - Vmin)/Vmax

♦        Continuous monophasic waveform without pulsatility = Normal pattern

♦        <0.3 pulsatility index with s and d waves above baseline = Mild abnormal pattern

♦       >0.3 pulsatility index with to and froaround the baseline= Severe abnormal pattern

Intrarenal Vein (RV): Kidney will be scanned at the posterior axillary line and color Doppler will be placed to look for the interlobar vessels. The pulse wave Doppler cursor will be placed at the best color Doppler signal and flow will be obtained.

♦        Continuous monophasic waveform below baseline = Normal pattern

♦        Biphasic S and D waves below baseline = Mild abnormal pattern

♦        Monophasic D wave below baseline = Severe abnormal pattern

Venous doppler ultrasound grading (VExUS)

The IVC diameter is measured then the portal, hepatic and intrarenal veins are scanned. Corresponding to a level of venous congestion, Doppler USG yields a specific pattern: normal, mild, or severe. According to the results, the VExUS score will be obtained as follows:

VExUS 0: IVC < 20mm;

VExUS 1: IVC  diameter  with normal patterns or mild abnormalities;

VExUS 2: IVC diameter and severe abnormality in at least one pattern

VExUS 3: IVC  diameter and severe abnormalities in multiple patterns

 

The VExUS score will be correlated with cumulative fluid balance. The patient will be followed for development of new onset Acute Kidney Injury using  AKIN criteria, need for renal replacement therapy, number of mechanical ventilation free days, ICU length of stay will be recorded.

Withdrawal criteria: If there is difficulty in obtaining the window for performing the Doppler Study, then that patient will be withdrawn from this study
Ethical considerations: Performing USG of the abdomen is routine clinical practice
 
 
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