Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Plasma-lyte 148

Criteria

Inclusion Criteria:

1. Age - 18-75 yrs of age

2. Cirrhotic patients with sepsis induced hypotension defined as mean arterial pressure less than 65mm of Hg with suspected (as per history and examination) or documented evidence of infection.

Exclusion Criteria:

1. Patients with other causes of hypotension

2. Patients who have already received bolus of 5% albumin or plasmalyte or >2L of fluids

3. Patients with structural heart disease or known diastolic dysfunction or cirrhotic cardiomyopathy

4. Patients who are on vasopressors or inotropes,

5. Patients already receiving renal replacement therapy

6. Patients with known chronic obstructive lung disease or congestive heart failure

7. Patients with serum albumin below 1.5 g/dl

8. Patients in need of surgical intervention

9. Pregnant or lactating women

10. Patients with a previous adverse reaction to human albumin.