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

NCT06076330 | Unknown

• 1 other identifier: ILBS-Cirrhosis-64
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving Mean Arterial Pressure above 65mm of Hg at 3 hrs after intervention

  3 hours

Secondary Outcomes (18)

• Proportion of patients with reversal of shock in the two groups.

  6 hours

• Proportion of patients with reversal of shock in the two groups.

  12 hours

• Proportion of patients with reversal of shock in the two groups.

  24 hours

• Effect of fluid resuscitation on lactate clearance in the two groups.

  0 hour

• Effect of fluid resuscitation on lactate clearance in the two groups.

  1 hour

Study Arms (2)

20% albumin infusion with plasmalyte

EXPERIMENTAL

* Plamalyte will be given at an initial bolus of 15-20 ml/kg over 15-30 mins followed by 100ml/hr maintenance * S. albumin \> 3 g/dl: 20g of 20% iv albumin @10-15 ml/hr * S. albumin \< 3 g/dl: 40g of 20% iv albumin @10-15 ml/hr

Biological: 20% Albumin; Drug: Plasmalyte

5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose

ACTIVE COMPARATOR

5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose * In case of failure to attain a sustained MAP \>65 mmHg, Fluid boluses will be administered guided by lung ultrasound and IVC * Group A: Plasmalyte bolus of 15-20 ml/kg over 15-30 mins * Group B: 5ml/kg of 5% albumin over 15-30 mins

Biological: 5% Albumin

Interventions

20% Albumin BIOLOGICAL

S. albumin \> 3 g/dl: 20g of 20% iv albumin @10-15 ml/hr S. albumin \< 3 g/dl: 40g of 20% iv albumin @10-15 ml/hr

20% albumin infusion with plasmalyte

5% Albumin BIOLOGICAL

5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose In case of failure to attain a sustained MAP \>65 mmHg, Fluid boluses will be administered guided by lung ultrasound and IVC.

5% albumin at an initial bolus of 5ml/kg iv over 15-30 mins followed by 50ml/hr maintenance dose

Plasmalyte DRUG

Plamalyte will be given at an initial bolus of 15-20 ml/kg over 15-30 mins followed by 100ml/hr maintenance

20% albumin infusion with plasmalyte

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Albumins; Plasmalyte A

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Ayush Jain, MD

CONTACT

01146300000; jainayush2206@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: September 30, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-09

Locations

IN (1)