Clinical study on the impact of albumin administration in preventing renal failure after cardiac surgery

20% Albumin infusion and AKI following cardiac surgery – Randomised Trial - ALBICS-AKI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003000-32-IT

Enrollment

590

Registered

2023-01-10

Start date

2023-06-23

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury (AKI) is a common complication of cardiac surgery. AKI is defined according to KDIGO criteria in 3 severity stages. KDIGO creatinine-based criteria for diagnosis and staging of AKI Stage Serum creatinine I 1.5–1.9 times baseline within 7 days

Interventions

Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: ALBUMINA UMANA SOLUZIONE CAS Number: 90604-29-8 Current Sponsor code: 90604-29-8 Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be included in the study, patients must meet all of the following inclusion criteria: Aged 18 years or older; Have undergone cardiac surgery; At least one of the following: i. Estimated glomerular filtration rate (eGFR) =65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: Patients meeting any of the following exclusion criteria will be excluded from the study: eGFR < 15 mL/min/1.73 m2, Serum albumin < 20 g/l, Dialysis dependence, Kidney transplant, Undergone off-pump cardiac surgery, Requiring extra-corporeal life support or ventricular assist device immediately postoperative, Jehovah’s Witness

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of postoperative 20% albumin infusion on incidence of AKI (stage I, stage II, stage III) after high-risk cardiac surgery.;Secondary Objective: Proportion of patients with In-hospital AKI stage II and III In-hospital mortality ICU LOS (hours) Hospital LOS (days) Ventilation time (hours);Primary end point(s): Reduction in the incidence of AKI (stage I, II and III) in the intervention group. The sample size for the study was determined by a priori power analysis. The anticipated incidence of AKI in the comparator group was based upon a cohort of over 25,000 patients that reported AKI in 30% of patients undergoing cardiac surgery [1]. Based on this estimate, the inclusion of 590 patients will achieve 80% power to detect a 10% absolute risk reduction in the risk of AKI (2-sided p = 0.05).;Timepoint(s) of evaluation of this end point: 28 days from enrolment or hospital discharge if it occurs before 28 days.	—

Measure

Time frame

Main Objective: To evaluate the impact of postoperative 20% albumin infusion on incidence of AKI (stage I, stage II, stage III) after high-risk cardiac surgery.;Secondary Objective: Proportion of patients with In-hospital AKI stage II and III In-hospital mortality ICU LOS (hours) Hospital LOS (days) Ventilation time (hours);Primary end point(s): Reduction in the incidence of AKI (stage I, II and III) in the intervention group. The sample size for the study was determined by a priori power analysis. The anticipated incidence of AKI in the comparator group was based upon a cohort of over 25,000 patients that reported AKI in 30% of patients undergoing cardiac surgery [1]. Based on this estimate, the inclusion of 590 patients will achieve 80% power to detect a 10% absolute risk reduction in the risk of AKI (2-sided p = 0.05).;Timepoint(s) of evaluation of this end point: 28 days from enrolment or hospital discharge if it occurs before 28 days.

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Countries

Italy, United Kingdom

Contacts

Public ContactPromotore sperimentazione

Monash Heath

yahya.shehabi@monashhealth.org+61419296986

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026