Efficacy of albumin with plasmalyte (drug) in the improvement of liver cirrhosis
- Conditions
- Health Condition 1: K768- Other specified diseases of liver
- Registration Number
- CTRI/2023/10/058589
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving MAP above 65mm of Hg at 3 hrs after interventionTimepoint: 3 hours
- Secondary Outcome Measures
Name Time Method Cumulative amount of fluid used in two armsTimepoint: 24 hours;Effect of fluid resuscitation on lactate clearance in the two groupsTimepoint: 0-1-3-6-12-24 hrs;Length of ICU stay in the two groupsTimepoint: 28 days;Mortality in both groupsTimepoint: 28 days;Proportion of patients with reversal of shock in the two groups.Timepoint: 6, 12, 24hrs;Time to initiation of norepinephrine in the two arms and the cumulative dose of norepinephrine in two armsTimepoint: 24 hours;To study the adverse effects (including pulmonary, metabolic and coagulopathy) in the two groupsTimepoint: 1-3-7-28 days