A Phase 2 interventional study of 7.5% NaCl in 6% dextran 70 solution in Heart Defects, Congenital, Transposition of Great Vessels and Heart Septal Defects, Ventricular, sponsored by Oslo University Hospital. Completed. Open to participants aged Up to 16 Weeks. Per ClinicalTrials.gov, last updated 2011-07-01.
Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment
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.
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's enrollment of 14 is below the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
IL-6 and IL-8 2 hours post CPB
Extra vascular lung water 2 and 24 hours post CPB
Fluid balance
Weight gain
Cardiac output
Intrathorasic blood volume
Blood pressure during the first 24 hours post CPB
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Oslo University Hospital