Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07286643

Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis

Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-12-16

140

Participants Needed

1

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

* Point-of-care echocardiography is used to guide septic shock resuscitation in patients with severe sepsis in the intensive care unit (ICU), but without systematic evidence for efficacy in critically patients with Cirrhosis and Severe Sepsis. * Due to portal hypertension, these patients have a hyperdynamic circulation, increased capillary permeability, splanchnic arteriolar vasodilation, reduced effective circulating blood volume and may have latent cirrhotic cardiomyopathy (CCM). * Hence assessment of volume status and cardiac reserve using conventional central venous pressure (CVP) or mean arterial pressure (MAP) remains difficult. Novelty: * In two recent trials, the role of 5% albumin vs PlasmalyteTM (FRISC study)(1) and 20% albumin vs. PlasmalyteTM (ALPS study) (2) were reported as the primary resuscitation fluid. Neither trial showed a clear long term survival benefit of albumin over balanced salt solution (BSS). In fact, the ALPS trial reported that there was increased risk of pulmonary edema with use of 20% albumin as fluid resuscitation. * A major limitation of such trial data is that the focus is on choice of fluid rather than looking at hemodynamic goals of resuscitation, resulting in protocolized overzealous fluid administration. * This may result in albumin-related pulmonary edema, and precipitation of overt heart failure in patients with silent CCM. * POC-Echo-based fluid resuscitation can prevent pulmonary edema and consequently respiratory failure, while ensuring renal and tissue perfusion. * It is unclear if choice of fluid or appropriate targets of resuscitation drive the survival benefit in the intensive care management of cirrhosis with severe sepsis. Objectives: * The investigators will conduct an ICU based randomised controlled feasibility trial comparing two measures of resuscitation: Echocardiography (ECHO) Guided septic shock resuscitation vs. a modified Goal-Directed Fluid Therapy (GDT) as recommended by sepsis guidelines which use protocol fluids. * The study will validate the role of POC-Echo parameters as volume assessment tools (cardiac index, systemic vascular resistance index) to determine endpoints of fluid resuscitation and need for vasopressors. * Lastly, the study aims to determine the presence of CCM in this population, and its impact on clinical outcomes. Methods POC-ECHO will be done within 1 hours of admission to the liver ICU and at 24h, 48 h and 72 hours in patients with cirrhosis with systolic blood pressure of \<90 mmHg or a mean arterial pressure \<65 mmHg. Resuscitation target is maintenance of MAP ≥65 mmHg with use of fluids and/or vasopressors. Clinical, cardiac biomarkers, and survival data based on resuscitation fluids will be prospectively collected. CCM will be defined as per CCM Consortium (2020) criteria. Expected outcome. The key questions to be answered in the resuscitation of critically ill patients with cirrhosis and sepsis induced hypotension are: 1. What should be best method of ensuring adequate fluid resuscitation i.e. fluid resuscitation protocol? 2. Which measurable clinical parameter can be used to determine adequacy of fluid resuscitation, and as a predictor of mortality outcomes at 7 and 28 days? 3. Whether early fluid resuscitation translates into better clinical outcome in decreasing duration of hospital and intensive care unit (ICU) stay, prevention of AKI and prevention of secondary sepsis?

CONDITIONS

Official Title

Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Critically ill patient with cirrhosis of any etiology
  • Sepsis-related hypotension with mean arterial pressure less than 65 mmHg or systolic blood pressure less than 90 mmHg
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • Currently receiving vasopressors or inotropes
  • Severe pre-existing cardiopulmonary disease such as porto-pulmonary hypertension, coronary artery disease, congenital or valvular heart disease, prosthetic cardiac valves, dilated or restrictive cardiomyopathy
  • Poor chest wall imaging window due to left pleural effusion, pneumothorax, or small intercostal spaces
  • Active bleeding like variceal bleed
  • History of cerebrovascular events
  • Chronic renal disease at end stage or on renal replacement therapy
  • Admission to ICU following liver transplantation, burns, or cardiac surgery
  • Previous transjugular intrahepatic portosystemic shunt (TIPS)
  • Hepatocellular carcinoma
  • Pregnant or lactating women
  • Refusal of informed consent by patient or attendants
  • Active COVID-19 infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

PGIMER Chandigarh

Chandigarh, India, 160012

Actively Recruiting

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Research Team

D

Dr Madhumita Premkumar, DM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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