Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial.
Phase 4
Completed
- Conditions
- regulation of COP during CPB10010394
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Infants with body weight lower or equal to 10 kg, elective operation
Exclusion Criteria
Infants with body weight of more than 10 kg.
Reoperations
Urgent operations
Premature
Infants with kidney and or liver insufficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patients will be weighted immediately preoperatively and postoperatively before<br /><br>leaving the OR. At the same moments extravascular lung water (EVLWI) will be<br /><br>measured with the PiCCO monitor.<br /><br>Ratio between the fraction of inspired oxygen and the partial pressure of<br /><br>oxygen in arterial blood (PaO2/FiO2) and positive end - expiratory pressure<br /><br>(PEEP) will be recorded preoperatively, before leaving the OR, at 4 and 24 hour<br /><br>postoperatively. Hemoglobin concentration (Hb), Hematocrit (Hct) and platelet<br /><br>count (Pl), COP and serum albumin concentration (Alb) will be measured<br /><br>preoperatively and before leaving the OR, during the CPB at the 5 minutes on<br /><br>bypass and at the end. During the postoperative period, measurements will be<br /><br>performed at 4 and 24 hours in the ICU.</p><br>
- Secondary Outcome Measures
Name Time Method <p>CPB data such as; CPB time, aortic cross-clamp time, lowest nasopharyngeal<br /><br>temperature, and surgery data, length of stay at the ICU and duration of<br /><br>mechanical ventilation will be collected during the study period. Type and<br /><br>volume of all crystalloid, colloid and blood components administrated in the<br /><br>OR, including transfusion during the CPB, and administrated during the stay at<br /><br>the ICU will be noted.<br /><br>Intraoperative and postoperative blood loss and urine output will be recorded,<br /><br>together with intraoperative and postoperative use of diuretics.</p><br>