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NCT Number: NCT06535945

Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

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Key information

Conditions

Liver Transplantation Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

08_CHRU de Tours Hôpital Trousseau, Chambray-lès-Tours, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects equal or above 18 yrs old.
  • Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
  • Capability of understanding the purpose and risks of the study.
  • Written informed consent

Exclusion criteria

  • Fulminant hepatitis
  • Kidney injury at baseline (Estimated Glomerular Filtration Rate < 50 ml/min in Modification of diet in renal disease-6) including hepatorenal syndrome
  • Use of an induction agent Basiliximab at liver transplantation
  • Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty

Treatment and study plan

Albumin administration

Drug

when albumin serum concentration is at 30 g/L or below

Primary outcomes

  1. Acute Kindey Injury at Day 7

    Time frame: 7 days after liver transplantation

    To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

Secondary outcomes

  1. Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation

    Time frame: 7 days after liver transplantation

    Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation

  2. hospital length of stay

    Time frame: 28 days

    hospital length of stay

  3. occurrence of calcineurin inhibitor induced neurotoxicity

    Time frame: 28 days

    occurrence of calcineurin inhibitor induced neurotoxicity

  4. occurence of calcineurin inhibitor withdraw

    Time frame: 28 days

    occurence of calcineurin inhibitor withdraw

  5. occurrence of postoperative infections

    Time frame: 28 days

    occurrence of postoperative infections

  6. occurrence of acute graft rejection

    Time frame: 28 days

    occurrence of acute graft rejection

  7. occurrence of early graft dysfunction

    Time frame: 28 days

    occurrence of early graft dysfunction

  8. duration of mechanical ventilation

    Time frame: 28 days

    duration of mechanical ventilation

  9. reintubation rate

    Time frame: 28 days

    reintubation rate

  10. Intensive Care Unit length of stay

    Time frame: 28 days

    Intensive Care Unit length of stay

  11. Intensive Care Unit readmission rate

    Time frame: 28 days

    Intensive Care Unit readmission rate

  12. All cause mortality

    Time frame: 28 days

    All cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Loïc JACOB

CONTACT

[email protected]

+33299282555

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: HALT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 2, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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