Efficacy of albumin with plasmalyte (drug) in the improvement of liver cirrhosis

Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension. A Randomized Controlled Trial (ALPS Plus). - ALPS Plus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058589

Enrollment

120

Registered

2023-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: 20% albumin infusion with plasmalyte: Plasmalyte dose - initial bolus of 15-20ml/kg over 15-30mins followed by 100ml/hr

S. Albumin 3g/dl - 20g/d @ 10-15 ml/hr Further boluses of plasmalyte will be given on the basis of IVC and lung ultrasound

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving MAP above 65mm of Hg at 3 hrs after interventionTimepoint: 3 hours	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Rakhi Maiwall

Institute of Liver and Biliary Sciences

rakhi_2011@yahoo.co.in01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026