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CTRI Number  CTRI/2025/04/085206 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effect of impaired heart relaxation on Mortality in Critically Ill ICU Patients: A Prospective Observational Study 
Scientific Title of Study   Diastolic dysfunction and severity as predictor of mortality in critically ill ICU patients in a Tertiary care centre - 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  VENKATESH MC 
Designation  Senior Resident 
Affiliation  King Georges Medical university 
Address  Department of Critical care medicine , King Georges medical university Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9080771847  
Fax    
Email  venkatabi1825@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avinash Agrawal 
Designation  Professor & HOD 
Affiliation  King Georges Medical university 
Address  Department of Critical care medicine , King Georges medical university Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  919838677999  
Fax    
Email  avinashagrawal@kgmcindia.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Avinash Agrawal 
Designation  Professor & HOD 
Affiliation  King Georges Medical university 
Address  Department of Critical care medicine , King Georges medical university Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  919838677999  
Fax    
Email  avinashagrawal@kgmcindia.edu  
 
Source of Monetary or Material Support  
Study requires no funding . Screening ECHO is routinely done and investigations are done as per case to case basis on discretion of treating physician 
 
Primary Sponsor  
Name  Venkatesh MC 
Address  Department of Critical care medicine King Georges Medical University Lucknow  
Type of Sponsor  Other [Self] 
 
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 
Venkatesh MC  King George Medical University  ICU of Department of critical care medicine Shah mina road Chowk , Lucknow 226003
Lucknow
UTTAR PRADESH 
9080771847

venkatabi1825@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KGMU Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I503||Diastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with age above 18 years & less than 80 years admitted to ICU will be included .
Informed consent to participate in study
Documented diastolic variable with 24-48 hours  
 
ExclusionCriteria 
Details  Age more than 80 years
Known cardiac disease or systolic dysfunction or valvular heart disease  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of all cause mortality between patients with diastolic dysfunction and without diastolic dysfunction   Comparison of all cause mortality between patients with diastolic dysfunction and without diastolic dysfunction  
 
Secondary Outcome  
Outcome  TimePoints 
number of days of
mechanical ventilation , hemodynamic instability in terms of vasopressor requirement , organ
dysfunction will be recorded and correlated for association with diastolic dysfunction and
mortality 
30 days  
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   30/05/2025 
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="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  
Diastolic dysfunction  is a significant concern in critically ill patients admitted to the
intensive care unit , and it has been associated with increased morbidity and
mortality. The relationship between diastolic dysfunction and mortality in ICU patients is
multifaceted and influenced by several factors. Diastolic dysfunction can lead to
hemodynamic instability, making it harder to manage fluid balance and blood pressure in
critically ill patients. Patients with diastolic dysfunction may have a limited ability to increase
cardiac output in response to stress, leading to inadequate tissue perfusion. Poor cardiac
relaxation and elevated filling pressures can contribute to multi-organ dysfunction, a common
cause of mortality in ICU settings. Studies have shown that diastolic dysfunction is
independently associated with higher mortality rates in ICU patients. The severity of diastolic
dysfunction correlates with worse outcomes. ICU patients with diastolic dysfunction often
have longer ICU and hospital stays, increased need for mechanical ventilation, and higher
rates of complications. Addressing underlying conditions such as hypertension, diabetes, and
sepsis can help improve diastolic function. Early detection and appropriate management of
diastolic dysfunction, along with addressing underlying causes and careful hemodynamic
monitoring, are essential to improve outcomes in these patients. Continued research and
awareness are necessary to refine strategies for managing diastolic dysfunction in the ICU
settings. I will be undertaking this study as very less number of studies have been done till
date and to find out the association between diastolic dysfunction and mortality in critically
ill ICU patients.
Diastolic left ventricular (LV) dysfunction is associated with slow LV relaxation and
increased LV stiffness. Cardiac dysfunction in critical care patients may contribute to
multiorgan failure and increased mortality . Diastolic dysfunction can be the reason for
intensive care unit (ICU) admission, or be a result from critical illness.
Doppler echocardiographic assessment of early (E-wave) and late (A-wave) diastolic filling
and the mitral annular early diastolic velocity (e’), as well as E/A and E/e’ ratios, have been
used to diagnose diastolic dysfunction . Abnormal values with different cut-offs have been
associated with worse outcomes and increased mortality.
Sanfilippo F et al documented in patients with sepsis, diastolic dysfunction has a better
correlation with mortality than left ventricular systolic dysfunction . Increased mortality is
seen with sepsis patients with diastolic dysfunction and higher grades with worst outcomes .
Lanspa et al proposed a simple definition for diastolic dysfunction based on Echo . According
to this definition, patients with e’sep < 8 are diagnosed to have diastolic dysfunction. They
are further graded based on E/e’; < 8, patients are classified as grade 1; 8–13, patients are
classified as grade 2; and if over 13, patients are classified as grade 3 .These parameters
outperformed ASE American Society of Echocardiography 2009 and 2016 guidelines for
diastolic dysfunction .
Diastolic dysfunction could be more prevalent in patients with more advanced disease or be a
part of multiorgan failure with an associated increase in mortality. Patients with diastolic
dysfunction have lower PaO2/FiO2 secondary to pulmonary congestion caused by higher
filling pressures , which has been shown to lead to extubation failure .
 
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