Comparison of the effect of 4% albumin and Ringer´s acetate in cardiopulmonary bypass (CPB) and intra- and postoperative volume replacement.

Albumin in cardiac surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002556-27-FI

Enrollment

1250

Registered

2016-11-10

Start date

2016-11-25

Completion date

Unknown

Last updated

2021-05-10

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

Conditions

Cardiac surgery with cardiopulmonary bypass operations. Elective and emergency patients. MedDRA version: 19.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 100000004863

Interventions

Trade Name: Albuman 40 g/l (Sanquin, the Netherlands) Product Name: Albuman Pharmaceutical Form: Infusion Other descriptive name: HUMAN ALBUMIN SOLUTION Trade Name: Albuman 200 g/l (Sanquin, the Neth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 18-90 years. following primary or repeat cardiac surgery procedures either independently or in combinations ( CABG, Valve-, MAZE, Surgery on the aortic root or ascending aorta not requiring hypothermic arrest). Elective or urgent surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 625 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 625

Exclusion criteria

Exclusion criteria: Immediate emergency surgery (no time for recruitment), End-stage kidney disease,

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare 4% albumin / 20% albumin vs ringer´s acetate as a priming solution of cardiopulmonary bypass and intra- and postoperative volume replacement in composite endpoint´s.;Secondary Objective: Secondary on other adverse events and tertiary on biochemical and physiological values;Primary end point(s): Primary outcome: Composite endpoint´s: all cause death, acute myocardial infarction, repeated revascularisation, acute heart failure, resternotomy, stroke, arrhytmia, major bleeding, infections, acute kidney injury.;Timepoint(s) of evaluation of this end point: 90 days postop.	—

Measure

Time frame

Main Objective: To compare 4% albumin / 20% albumin vs ringer´s acetate as a priming solution of cardiopulmonary bypass and intra- and postoperative volume replacement in composite endpoint´s.;Secondary Objective: Secondary on other adverse events and tertiary on biochemical and physiological values;Primary end point(s): Primary outcome: Composite endpoint´s: all cause death, acute myocardial infarction, repeated revascularisation, acute heart failure, resternotomy, stroke, arrhytmia, major bleeding, infections, acute kidney injury.;Timepoint(s) of evaluation of this end point: 90 days postop.

—

Secondary

Measure	Time frame
Secondary end point(s): Total number of MAE´S, number of each type blood product transfused, fluid balance, blood loss, acute kidney injury, days alive without mecanical intubation in 90 days, days alive outside ICU 90 in days. Days alive at home in 90 d. 90 days mortality;Timepoint(s) of evaluation of this end point: 24 h postop, 90 days post op.	—

Countries

Finland

Contacts

Public ContactMeilahti Hospital

Helsinki University Hospital

eero.pesonen@hus.fi+35894711

Outcome results

None listed

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