Hypertonic Saline Dextran in Pediatric Cardiac Surgery
Phase 2
Completed
- Conditions
- Heart Defects, CongenitalTransposition of Great VesselsHeart Septal Defects, VentricularEndocardial Cushion Defects
- Registration Number
- NCT00199771
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
- Detailed Description
After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
- Age below 17 weeks
Exclusion Criteria
- Preoperative: organ failure (other than heart), serum sodium > 155 mmol/l, central venous pressure > 12 mmHg
- Perioperative: core temperature < 25 ºC on CPB, re-heparinization, re-operation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method IL-6 and IL-8 2 hours post CPB Extra vascular lung water 2 and 24 hours post CPB
- Secondary Outcome Measures
Name Time Method Fluid balance Weight gain Cardiac output Intrathorasic blood volume Blood pressure during the first 24 hours post CPB