Echocardiography-guided intensive care for septic shock in people with cirrhosis

Point-of-care Echocardiogram (POCUS) Guided Resuscitation Versus Conventional Goal- Directed Therapy in the Management of Cirrhosis With Severe Sepsis or Septic Shock: A Randomised Controlled Trial

This study will try using bedside ultrasound (POCUS) to guide fluid and blood-pressure treatment in adults with cirrhosis who develop sepsis-related low blood pressure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh (Academic / other)
• Locations: 1 site (Chandigarh)
• Trial ID: NCT07286643 on ClinicalTrials.gov

What this trial studies

This interventional protocol enrolls critically ill adults with cirrhosis and sepsis-related hypotension and uses point-of-care transthoracic echocardiography to guide fluid resuscitation and vasoactive therapy rather than relying only on fixed pressure targets. Patients who meet inclusion criteria and consent are managed in the ICU with serial POCUS assessments of cardiac function and volume status to tailor therapy. The protocol excludes patients already on vasopressors, with severe cardiopulmonary disease, active major bleeding, advanced renal failure, post‑transplant status, or poor echocardiographic windows. Outcomes focus on hemodynamic stabilization and clinical complications associated with fluid and vasopressor use in this high‑risk population.

Who should consider this trial

Good fit: Adults aged 18–65 with cirrhosis of any cause who are newly hypotensive from sepsis (MAP <65 mmHg or SBP <90 mmHg), not already on vasopressors, and able to undergo bedside echocardiography are the intended participants.

Not a fit: Patients already receiving vasopressors/inotropes, with severe preexisting cardiopulmonary disease, active variceal bleeding, end-stage renal disease on dialysis, recent liver transplant, poor chest echo windows, or who are pregnant are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, POCUS-guided management could reduce unnecessary fluids or inappropriate vasopressor use and lower complications or deaths in cirrhotic patients with septic shock.

How similar studies have performed: Bedside echocardiography has been used to guide resuscitation in general sepsis cohorts with mixed results, and recent albumin versus balanced-salt trials in cirrhosis did not show clear survival benefit, while POCUS-guided strategies remain largely untested specifically in cirrhotic septic patients.

Eligibility criteria

Inclusion Criteria:

1. Critically ill patient with cirrhosis of any etiology
2. Sepsis-related Hypotension (MAP \<65mmHg or SBP \<90mmHg)
3. 18-65 yrs of age -

Exclusion Criteria:

1. Already on vasopressors/inotropes
2. Severe pre-existing cardiopulmonary disease like porto-pulmonary hypertension (PPH), known coronary artery disease, congenital or valvular heart disease, prosthetic cardiac valves, dilated or restrictive cardiomyopathy.
3. Poor chest wall window due to left pleural effusion, left pneumothorax, small intercostal spaces that restrict performance of a POCUS.
4. Active bleeding like variceal bleed
5. Cerebrovascular events
6. Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy
7. Admission to ICU following liver transplantation, burns, cardiac surgery
8. Previous transjugular intra hepatic portosystemic shunt (TIPS),
9. Hepatocellular carcinoma
10. Pregnant or lactating women
11. Informed consent refused by patient or attendants
12. Active COVID-19 infection

Where this trial is running

Chandigarh

• PGIMER Chandigarh — Chandigarh, India (Recruiting)

Study contacts

• Study coordinator: Dr Madhumita Premkumar, DM

Conditions Cirrhosis, Liver; Cirrhotic Cardiomyopathy; Septic Shock; echocardiography; cardiac output monitoring; hemodynamics; fluid resuscitation.; POCUS