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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2023-12-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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20% Albumin arm

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

Group Type EXPERIMENTAL

20% albumin

Intervention Type DRUG

Albumin arm for resuscitation fluid

Balanced salt solution

Intervention Type DRUG

Only Balanced salt solution will be used.

Balanced salt solution arm

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.

Group Type ACTIVE_COMPARATOR

Balanced salt solution

Intervention Type DRUG

Only Balanced salt solution will be used.

Interventions

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20% albumin

Albumin arm for resuscitation fluid

Intervention Type DRUG

Balanced salt solution

Only Balanced salt solution will be used.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes