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CTRI Number  CTRI/2024/06/068480 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observational study in critically ill chronic liver disease patients to find out the imbalance between right ventricular workload and functional capacity. 
Scientific Title of Study   Right ventricle-pulmonary artery uncoupling in critically ill decompensated chronic liver disease patients: an exploratory 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 Deepak K Tempe 
Designation  MBBS,MD,FRCA, FAMS, Professor &Head of Department of Anesthesiology 
Affiliation  Institute of Liver & Biliary Sciences 
Address  Department of Anesthesia, Phase: 2, 3rd floor. Institute of Liver & Biliary Sciences, Vasant Kunj

New Delhi
DELHI
110070
India 
Phone    
Fax    
Email  tempedeepak@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aniruddha Banerjee 
Designation  DM student 
Affiliation  Institute of Liver & Biliary Sciences 
Address  Department of Anesthesia, Phase: 2, 3rd floor. Institute of Liver & Biliary Sciences, Vasant Kunj

New Delhi
DELHI
110070
India 
Phone  08583807964  
Fax    
Email  banerjeeaniruddha194@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aniruddha Banerjee 
Designation  DM student 
Affiliation  Institute of Liver & Biliary Sciences 
Address  Department of Anesthesia, Phase: 2, 3rd floor. Institute of Liver & Biliary Sciences, Vasant Kunj


DELHI
110070
India 
Phone  08583807964  
Fax    
Email  banerjeeaniruddha194@gmail.com  
 
Source of Monetary or Material Support  
Institute Of Liver & Biliary Sciences 
 
Primary Sponsor  
Name  Institute of Liver and Biliary Sciences 
Address  Vasant Kunj, New Delhi,110070 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 Aniruddha Banerjee  Institute of Liver and Biliary Sciences  Department of Anesthesia, Phase 2, 3rd Floor, ILBS hospital, Vasant kunj, New Delhi.
New Delhi
DELHI 
8583807964

banerjeeaniruddha194@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe of Institute of Liver & Biliary Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis, (2) ICD-10 Condition: K721||Chronic hepatic failure, (3) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (4) ICD-10 Condition: K739||Chronic hepatitis, unspecified, (5) ICD-10 Condition: K729||Hepatic failure, unspecified, (6) ICD-10 Condition: K754||Autoimmune hepatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients with chronic liver disease with decompensation requiring ICU care.
Disease etiology: chronic liver disease or Acute on chronic liver disease of various etiology like alcoholic liver disease, viral hepatitis, NASH
 
 
ExclusionCriteria 
Details  Pediatric patients
acute coronary syndrome within 1week
Rhythm characteristics of atrial fibrillation
Prosthetic valves or valvular diseases such as severe mitral, aortic or tricuspid stenosis or regurgitation
An inadequate echocardiographic images for measurement
Patients without tricuspid regurgitation as TRV cannot be calculated in them.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine incidence of Right ventricle- Pulmonary artery uncoupling (by means of calculating TAPSE/PASP ratio) in patients with decompensated chronic liver disease requiring ICU care.  With in 48 hours of ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
Need for ventilatory support, inotrope requirement, Mortality  1st, 3rd, 7th, 14th, 21st, 28th day in ICU  
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   02/06/2025 
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="1"
Days="15" 
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  

Point of care Echocardiography has been a part of modern-day ICU training and an integral part of patient management. Use of point of care ultrasound (POCUS) in decision making and management of critical cases is increasing day by day.

 Right ventricular–pulmonary artery coupling (RV-PA coupling) refers to the relationship between RV contractility and RV afterload. Normal RV-PA coupling is maintained only when RV function and pulmonary vascular resistance are appropriately matched. RV-PA uncoupling occurs when RV contractility cannot increase to match RV afterload, resulting in RV dysfunction. Therefore, early and accurate evaluation of RV-PA coupling is of great significance for a patient’s condition assessment. Right ventricle (RV)-pulmonary artery (PA) uncoupling has been studied in patient with sepsis.[1,2,3].

Hemodynamics in critically ill liver disease patients resembles  sepsis and septic shock in the sense of  increased permeability of vessels, hyper-dynamic circulation, and decreased effective blood volume. Patients can develop RV dysfunction as a consequence of left ventricular (LV) dysfunction; however, cirrhotic cardiomyopathy, direct RV myocardial injury and increased RV afterload from increased pulmonary vascular resistance (PVR) are also important contributory factors. Chronic liver disease itself can cause ventricular dysfunction and pulmonary artery (PA) hypertension which can lead to RV- PA uncoupling.

 

RV performance is frequently assessed in isolation yet it is closely related to afterload; combined evaluation of the pulmonary circulation may be more beneficial at the bedside. The ratio of tricuspid annular plane systolic excursion (TAPSE) and PA systolic pressure (PASP) is deemed as an indicator of right ventricular pulmonary arterial coupling, the normal value being > 0.3.[4]

TAPSE is a simple and reproducible parameter of RV systolic function with low inter-observer variability, even in patients with raised right-sided pressures.[5,6] PASP can be reliably determined from the peak tricuspid regurgitation velocity in the majority of patients[7]. The TAPSE/PASP ratio was found to be associated with mortality in patients with pulmonary arterial hypertension and heart failure. [8,9]. A retrospective exploratory study   was conducted by Bowcock et al [3] on 131 patients on RVOT Doppler flow analysis and pulmonary artery coupling in sepsis. It was observed that increased PVR and RV-PA uncoupling (TAPSE/ PASP ratio < 0.31mm/mm Hg) were present in a significant portion of patient with sepsis.

Another prospective study was performed on 118 mechanically ventilated patient with septic shock by Zhang et al.[2] TAPSE/ PASP ratio demonstrated prognostic value for  ICU mortality , duration of mechanical ventilation.

References:

     1. Winkelhorst JC, et al: Right ventricular function and long term outcome in sepsis; a retrospective cohort study. Shock.2019.

2. Zhang et al. Prognostic implication o tricuspid annular plane systolic excursion/ pulmonary arterial systolic pressure ratio in septic shock patients. Cardiovascular ultrasound.2020.

3. Bowcock et al, Right ventricular outflow tract Doppler flow analysis and pulmonary arterial coupling by transthoracic echocardiography in sepsis: a retrospective exploratory study. Critical care. 2022

4. Kubba S et al, Methods for evaluating right ventricular function and ventricular arterial coupling. Progress in cardiovascular disease.2016.

5. Kaul et al. Assessment of right ventricular function using two dimensional echocardiography. Am Heart J. 1984

6.Hammarstrom E et al, Tricuspid Annular motion. J Am Soc echocardiography. 1991

7.Rudski L G et al, Guidelines for the echocardiographic assessment of right heart in adult. . J Am Soc echocardiography. 2010

8.Guazzi M et al, RV contractile function and its coupling to pulmonary circulation in heart failure with preserved ejection fraction: stratification of clinical phenotype and outcome. JACC cardiovasc imaging. 2017

9. Tello K et al, Relevance of the TAPSE/ PASP ratio in pulmonary arterial hypertension. Int J Cardiol. 2018


 
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