Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05700708
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2022-12-06
Brief Title:
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Point-of-care echocardiography POC-Echo is used to determine left ventricular systolic and diastolic dysfunction LVDD inferior vena cava IVC dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately
We will assess IVC dynamics LV systolic function LV ejection fraction EF cardiac output CO and diastolic dysfunction Ee e and EA ratio and urinary biomarkers cystatin C and NGAL in patients with cirrhosis and Refractory Ascites
We will assess IVC dynamics LV systolic function LV ejection fraction EF cardiac output CO and diastolic dysfunction Ee e and EA ratio and urinary biomarkers cystatin C and NGAL in patients with cirrhosis and Refractory Ascites
Detailed Description:
The decrease in systemic vascular resistance SVR and redistribution of blood volume with reduced intravascular volume compartment and third space fluid losses Systemic vasodilatation is compensated by an increase in cardiac output CO in the initial stages of compensated cirrhosis However as the stage of liver cirrhosis progresses to decompensation more prominent arterial vasodilatation and reduced SVR leads to a fall in CO Thus the cardiac homeostat is reset in a cirrhotic hyperdynamic circulation wherein an increased heart rate and therefore increased cardiac output will no longer be able to compensate for the reduced mean arterial pressure MAP and decreased blood volumes in central venous territories18 Consequent activation of vasoconstrictor systems including renin-angiotensin-aldosterone vasopressin and the sympathetic nervous system comes into play to maintain the intravascular blood volume and pressure These compensatory pathways cause an increase in sodium and water retention resulting in refractory ascites and hepatorenal syndrome HRS In critically ill patients with cirrhosis the limited cardiac reserve is further stressed CCM and heart failure may be diagnosed for the first time when the patient develops sepsis or septic shock
Point-of-care echocardiography POC-Echo is used to determine left ventricular systolic and diastolic dysfunction LVDD inferior vena cava IVC dynamics and volume status in cirrhosis accurately We will assess IVC dynamics LV systolic function LV ejection fraction EF cardiac output CO and diastolic dysfunction Ee e and EA ratio in patients with cirrhosis ACLF and refractory ascites
Definition of CCM is as per updated CCMC criteria of 2020
Point-of-care echocardiography POC-Echo is used to determine left ventricular systolic and diastolic dysfunction LVDD inferior vena cava IVC dynamics and volume status in cirrhosis accurately We will assess IVC dynamics LV systolic function LV ejection fraction EF cardiac output CO and diastolic dysfunction Ee e and EA ratio in patients with cirrhosis ACLF and refractory ascites
Definition of CCM is as per updated CCMC criteria of 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None