Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial - regulation of COP during CPB in infants
- Conditions
- Regulation of COP during CPB in infants
- Registration Number
- EUCTR2008-000069-41-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method