| 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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| Institute Of Liver & Biliary Sciences |
|
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Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Vasant Kunj, New Delhi,110070
India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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Intervention / Comparator Agent
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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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