Status:
UNKNOWN
Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 t...
Detailed Description
Hypothesis: Combination of 20% albumin with plasmalyte could be better than 5% albumin for fluid resuscitation in critically ill cirrhosis patients due to less incidence of hyperchloremic metabolic ac...
Eligibility Criteria
Inclusion
- Age - 18-75 yrs of age
- 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
- Patients with other causes of hypotension
- Patients who have already received bolus of 5% albumin or plasmalyte or \>2L of fluids
- Patients with structural heart disease or known diastolic dysfunction or cirrhotic cardiomyopathy
- Patients who are on vasopressors or inotropes,
- Patients already receiving renal replacement therapy
- Patients with known chronic obstructive lung disease or congestive heart failure
- Patients with serum albumin below 1.5 g/dl
- Patients in need of surgical intervention
- Pregnant or lactating women
- Patients with a previous adverse reaction to human albumin.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06076330
Start Date
September 30 2023
End Date
August 31 2024
Last Update
October 10 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070