NCT05441878

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

To Compare 20% Albumin vs. Balanced Salt Solution as Resuscitation Fluid and Identify Fluid Responsiveness Criteria in Critically Ill Patients With Cirrhosis With Sepsis Induced Hypotension; a Prospective Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Cirrhosis, Liver
• Acute-On-Chronic Liver Failure
• Shock, Septic
• Shock Hypovolemic

Interventions

Type	Name	Description
DRUG	20% albumin	Albumin arm for resuscitation fluid
DRUG	Balanced salt solution	Only Balanced salt solution will be used.

Timeline

• Start date: 2020-08-15
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-07-01
• Last updated: 2022-07-01

Locations

1 site across 1 country: India