Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial - regulation of COP during CPB in infants

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000069-41-NL

Enrollment

Registered

2008-01-22

Start date

2008-04-09

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Regulation of COP during CPB in infants

Interventions

Trade Name: Cealb Product Name: albumine Product Code: BO5AA01 Pharmaceutical Form: Concentrate for solution for infusion Other descriptive name: HUMAN ALBUMIN SOLUTION

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants with body weight of less than 10 kg undergoing elective first time cardiac surgery. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Infants with body weight of more than or equal to 10 kg. Infants who are indergoing second time (or more) cardiac surgery. Infants who are indergoing emergency surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: To reduce the transfusion of allogenic bloodproducts after CPB, impairment of pulmonary function following CPB will be attenuated and the recovery and length of ICU stay will be shorter.;Secondary Objective: ;Primary end point(s): the expected diminishing of fluid shift into the extravascular space which will result in higher levels of hematocrit and plateletcount in thte postoperative period.	—

Measure

Time frame

Main Objective: To reduce the transfusion of allogenic bloodproducts after CPB, impairment of pulmonary function following CPB will be attenuated and the recovery and length of ICU stay will be shorter.;Secondary Objective: ;Primary end point(s): the expected diminishing of fluid shift into the extravascular space which will result in higher levels of hematocrit and plateletcount in thte postoperative period.

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Countries

Netherlands

Outcome results

None listed

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