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

NCT06809088 | Not Yet Recruiting

• 1 other identifier: ILBS-AKI-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury accompanies about 20% of hospitalized patients with cirrhosis and in about 40% of those admitted to ICU.A critically ill patient with cirrhosis refers to an individual who has advanced liver disease (cirrhosis) and is experiencing severe and potentially life-threatening complications that require intensive medical care and monitoring. These complications might include hepatic encephalopathy, acute liver failure, severe bleeding due to portal hypertension, or other organ failures. Such patients often require specialized medical attention and interventions to stabilize their condition. The short-term prognosis of cirrhotic patients with acute kidney injury is poor, with a mortality rate higher than 65% in patients with RRT requirement. Patients with cirrhosis are prone to develop AKI . HRS comprises specific form of AKI\[HRS-AKI\] in patients with advanced cirrhosis and ascites, carries a high mortality risk. Role of albumin as colloid serves both as volume supplement and also as additive to vasoconstrictors. Ascites, elevated bilirubin, spontaneous bacterial peritonitis \[SBP\] and use of amino glycosides antibiotics had previously been identified as significant risk factors for renal failure in cirrhotic patients. The causes of AKI in cirrhotic patients include HRS \[most common\], others include ATN \[associated mostly with sepsis\]and hypovolemic shock. Three month survival ranged from 73% in patients with parenchymatous AKI to 15% for HRS. As per 2023 joint meeting of ICA and ADQI ,based on baseline serum creatinine\[sCr\](a lowest value obtained within the previous 3 months),AKI is defined by an absolute increases of sCr\>=0.3mg/dl within 48hr or a percentage increase of sCr\>=50% from baseline within 7 days and urine output \<= 0.5ml/kg for \>=6hrs.As per KDIGO ,three stages of AKI are defined :Stage 1\]when the previous criteria are met \[a relative increase of sCr 1.5-2.0from baseline, stage 2\]when increase in sCr is \>2folds to 3 folds from baseline and Stage 3\]when there is an increase of sCr\>3 folds from baseline or sCr is \>4.0mg/dl with an acute increase of \>0.3mg/dl or initiation of RRT. So, the study aims to analyze the role of albumin as a volume supplement and as a vasoconstrictor as well as its immunomodulatory effect in sepsis to help in resolution of AKI.Here we compare the effectiveness of personalized-dose albumin administration with fixed-dose albumin for treating acute kidney injury in patients with cirrhosis and sepsis associated AKI.

Conditions

Liver Cirrhosis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having resolution of AKI at 48hrs or 7days without the development of adverse events

  48hrs/7days

Secondary Outcomes (8)

• Cumulative dose of albumin (in g/day) used in both arms at 48 hours and day 7

  48 hours and day 7

• Time to initiation of vasoconstrictors and resolution of AKI

  7 days

• Proportion of patients requiring invasive or non-invasive mechanical ventilation at 48 hours and at day7

  48 hours and day 7

• Proportion of patients developing cardiopulmonary complications in both groups

  7 days

• 28-day mortality of hospitalized patients with AKI in Cirrhosis

  28 days

Study Arms (2)

Personalized Regimen

EXPERIMENTAL

* 25% albumin infusion with monitoring of * Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature * 3Hrly - POCUS, IVC Target \<20 with respiratory phase variability, Lung USG with absence of B lines , * Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index

Biological: Albumin

Standard medical therapy

ACTIVE COMPARATOR

As defined in Revised consensus of International Club of Ascites and ADQI for AKI resolution Dosing of Albumin to be kept at 1gm/KG body weight daily * Hrly - MAP, HR, Urine output, Respiratory rate,SpO2 ,Temperature * 3Hrly - POCUS, IVC Target \<20 with respiratory phase variability, Lung USG with absence of B lines , * Daily - S.Cr, eGFR, Chest Xray, 2D Echo,Renal Resistive Index, SOFA scoring

Other: Standard Medical Treatment

Interventions

Albumin BIOLOGICAL

Albumin

Personalized Regimen

Standard Medical Treatment OTHER

Standard Medical Treatment

Standard medical therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Liver Cirrhosis; Acute Kidney Injury

Interventions

Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Shreyas Sarvesh, MD

CONTACT

01146300000; shreyassarvesh@gmail.com

Dr Rakhi Maiwall, DM

CONTACT

01146300000; rakhi_2011@yahoo.co.in

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: January 29, 2025
• First Posted: February 5, 2025
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

IN (1)