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

NCT06076330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-10

No results posted yet for this study

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

Interventions

BIOLOGICAL

20% Albumin

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

5% Albumin

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.

DRUG

Plasmalyte

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076330 on ClinicalTrials.gov