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

Postgraduate Institute of Medical Education and Research

Status and phase: Enrolling; Phase 4

Conditions: Acute-On-Chronic Liver Failure; Cirrhosis, Liver; Shock, Septic; Shock Hypovolemic

Treatments: Drug: Balanced salt solution; Drug: 20% albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT05441878

IEC/11/2019/1496

Details and patient eligibility

About

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 .

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

20% Albumin arm

Experimental group

Description:

20% Albumin in a dose of 20-40 gm per day as infusion over 12-24 h

Treatment:

Drug: 20% albumin

Drug: Balanced salt solution

Balanced salt solution arm

Active Comparator group

Description:

Fluid resuscitation protocol includes use of an immediate 500 ml bolus of crystalloid i.e., balanced salt solution (BSS) or 0.9% normal saline (Rescue phase), followed by 20 ml/kg fluid in the first 6 hours titrated to target MAP of > 65mmHg.The second phase of fluid resuscitation (Optimization phase) will be performed as per IVC targets, attainment of lactate clearance, and LUS score to prevent overload.

Treatment:

Drug: Balanced salt solution