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Search / Trial NCT06809088

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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 4, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to use albumin, a protein found in blood, to treat patients with cirrhosis (a serious liver condition) and acute kidney injury (AKI) that can occur with infections. The researchers want to compare two methods: giving a set amount of albumin (fixed dose) versus tailoring the amount based on each patient's needs (tailored dose). The goal is to see which approach helps patients recover better from kidney problems while they are being treated for their liver condition and infections.

To participate in this trial, patients need to be between 18 and 70 years old and have both cirrhosis and AKI due to an infection. Unfortunately, those who have certain other health issues, like severe heart problems or are on dialysis, cannot join. If someone is eligible, they can expect to receive either the fixed-dose or tailored albumin treatment during their hospital stay. It's important to note that this trial is not yet recruiting participants, but it aims to improve outcomes for patients facing these serious health challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age \>18 and \<70
  • 2. patients with cirrhosis and AKI with sepsis.
  • Exclusion Criteria:
  • 1. AKI- secondary to post renal causes such as nephrolithiasis
  • 2. Patient already on maintenance hemodialysis/RRT
  • 3. Patients with shock requiring vasopressors
  • 4. Patient with history of structural heart disease and LVEF \< 50%
  • 5. Patient with known COPD
  • 6. Patient on Mechanical ventilation with P/F ratio \<200
  • 7. Patient with POCUS based features of volume overload\[Presence of B lines \]
  • 8. HCC - Beyond MILAN criteria
  • 9. Patient in need of surgical intervention
  • 10. Patient with history of adverse reaction to Albumin infusion
  • 11. Pregnant or Lactating Women
  • 12. Portal or hepatic vein thrombosis
  • 13. Volume Overload with baseline IVC \>20
  • 14. Failure to provide informed consent

About Institute Of Liver And Biliary Sciences, India

The Institute of Liver and Biliary Sciences (ILBS) in India is a premier research and healthcare institution dedicated to the advancement of knowledge and treatment in liver, biliary, and related diseases. As a clinical trial sponsor, ILBS is committed to conducting innovative and ethically-driven research to improve patient outcomes and enhance therapeutic options in hepatology. The institute fosters collaboration among multidisciplinary teams of clinicians, researchers, and healthcare professionals, ensuring rigorous scientific methodologies and adherence to regulatory standards. Through its focus on translational research, ILBS aims to bridge the gap between laboratory discoveries and clinical applications, ultimately contributing to the global understanding and management of liver diseases.

Locations

New Delhi, Delhi, India

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported