Clinical Trial: Hypertonic Saline Dextran in Pediatric Cardiac Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
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 Summary: 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.
Sponsor: Oslo University Hospital
Current Primary Outcome:
- IL-6 and IL-8 2 hours post CPB
- Extra vascular lung water 2 and 24 hours post CPB
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Fluid balance
- Weight gain
- Cardiac output
- Intrathorasic blood volume
- Blood pressure during the first 24 hours post CPB
Original Secondary Outcome: Same as current
Information By: Oslo University Hospital
Dates:
Date Received: September 13, 2005
Date Started: June 2003
Date Completion:
Last Updated: June 30, 2011
Last Verified: January 2008
