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

RecruitingNAAges 18 Years - 65 YearsAllPost Graduate Institute of Medical Education and …
NCT07286643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

* 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

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📋 Eligibility rules (as published)
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
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What it tests

  • POCUS
  • Fixed Resuscitation Strategy based on Target MAP
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Where

1 site
PGIMER Chandigarh
Chandigarh, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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