Cirrhosis, Liver, Acute-On-Chronic Liver Failure, Shock, Septic, Shock Hypovolemic
Conditions
Brief 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 .
Interventions
DRUG20% albumin
Albumin arm for resuscitation fluid
Only Balanced salt solution will be used.
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess IVC dynamics. | At enrolment | To compare the IVC dynamics in patients with cirrhosis and sepsis induced hypotension |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess dynamic changes in cardiac output, stroke volume and E/e' echocardiographic parameters. | At enrolment | To compare the cardiac output in patients with cirrhosis and sepsis induced hypotension |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension and assess new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI) | At enrolment | To compare the new onset of hepatorenal syndrome (HRS) or acute kidney injury (AKI)in patients with cirrhosis and sepsis induced hypotension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary marker of AKI (NGal) | At enrolment | — |
| To compare the efficacy of 20% Albumin vs Plasmalyte in the first 3 -6 hours of volume resuscitation in cirrhosis with sepsis induced hypotension., and assess vasopressor requirement | At enrolment | To compare the vasopressor requirement in patients with cirrhosis and sepsis induced hypotension |
| Change in urinary markers of AKI (NGal) | At 24 hours. | — |
| Change in urinary markers of AKI(NGal) | At 48 hours. | — |
Countries
India
Contacts
Primary ContactMadhumita Premkumar, DM
Outcome results
None listed