20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid in Cirrhosis With Sepsis Induced Hypotension

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    150
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 4 October 2022
antibiotics
ascites
encephalopathy
shock
Accepts healthy volunteers

Summary

Patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. About 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . After infection develops, the patient may develop acute kidney injury (AKI), shock, encephalopathy or disseminated intravascular coagulation (DIC) further decreasing the chances of survival. In fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. So, sepsis is directly responsible for 30-50% of deaths in cirrhosis . Therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. Early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. Currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (EGDT) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . The use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .

Details
Condition Cirrhosis, Liver, Acute-On-Chronic Liver Failure, Shock, Septic, Shock Hypovolemic
Treatment 20% Albumin, Balanced Salt Solution
Clinical Study IdentifierNCT05441878
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical/Imaging or Biopsy proven liver cirrhosis of any etiology who consent for enrolment
Hypotension (Mean arterial pressure <65mmHg or Systolic blood pressure <90mmHg)
Aged between18-65 yrs

Exclusion Criteria

Already received colloid or more than 2 litres of fluid without baseline echocardiographic assessment
Already on vasopressors/inotropes
Severe pre-existing cardiopulmonary disease
Acute Respiratory Distress Syndrome (ARDS)
Active bleeding like variceal bleed
Cerebrovascular events
Chronic renal disease - End Stage Renal Disease (ESRD)/ patient on renal replacement therapy
Admission to ICU following liver transplantation, burns, cardiac surgery
Brain death or likely brain death within 24 hours
Previous adverse reaction to human albumin solution
Pregnant or lactating women
Informed consent refused by patient or attendants
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