Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis and Sepsis Associated Acute Kidney Injury

Study population:

• Age - 18-70 years

Study design: Monocentric open label randomised controlled study. The study will be conducted in Department of Hepatology ILBS.

Primary Objective : Effect of personalized dose of albumin compared to fixed dose protocol in improving AKI resolution at 48 hrs.

Secondary objectives:

• To study the cumulative dose of albumin in both groups.
• Time to AKI resolution and initiation of vasoconstrictors in both the groups
• Incidence of cardiopulmonary complications in both groups
• Impact of dose of albumin on cardiac function [including CVP and IVC], intraabdominal pressure and renal perfusion [assessed by renal artery resistive index] in both groups at 24 hr and 48 hrs.
• To study the role of intraabdominal pressure, Lung USG , biomarkers of cardiac dysfunction [NT Pro BNP, Troponin T] in predicting the development of cardiopulmonary complications and AKI outcomes.
• To study the duration of AKI and need of dialysis in both groups.
• 28-day mortality in both groups

Stopping Rule:

• With the development of cardiorespiratory adverse effects

• Increase in Heart rate > 10 from basal value
• Increase in RR > 20/min
• Temp > 1000 F
• SpO2 < 96%
• B lines in Lung USG
• IVC >= 20 with collapsibility <50% or distensibilty <18%
• Development of allergy
• On worsening shock ,if Noradrenaline requirement increases >0.1mcg/kg bw/min
• worsening AKI with a]decrease in urine output b]Need of Terlipressin c]Start of RRT
• If Downstaging of AKI does not occur on 48hr of Albumin infusion then based on GFR and urine output decision to add vasoconstrictor to be taken

Inclusion criteria

• Age >18 and <70
• patients with cirrhosis and AKI with sepsis.

Exclusion criteria

• AKI- secondary to post renal causes such as nephrolithiasis
• Patient already on maintenance hemodialysis/RRT
• Patients with shock requiring vasopressors
• Patient with history of structural heart disease and LVEF < 50%
• Patient with known COPD
• Patient on Mechanical ventilation with P/F ratio <200
• Patient with POCUS based features of volume overload[Presence of B lines ]
• HCC - Beyond MILAN criteria
• Patient in need of surgical intervention
• Patient with history of adverse reaction to Albumin infusion
• Pregnant or Lactating Women
• Portal or hepatic vein thrombosis
• Volume Overload with baseline IVC >20
• Failure to provide informed consent