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Sponsors and Collaborators: |
Rikshospitalet HF BioPhausia |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00199771 |
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.
Condition | Intervention | Phase |
---|---|---|
Heart Defects, Congenital Transposition of Great Vessels Heart Septal Defects, Ventricular Endocardial Cushion Defects |
Drug: 7.5% NaCl in 6% dextran 70 solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old. |
Estimated Enrollment: | 14 |
Study Start Date: | June 2003 |
Study Completion Date: | February 2005 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 16 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Rikshospitalet-Radiumhospitalet HF ( Gunnar Bentsen / Consultant ) |
Study ID Numbers: | 2003-HSD, S-01003 (ethics committee) |
Study First Received: | September 13, 2005 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00199771 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency |
Cardiac Surgery Infant Infant, Newborn Hypertonic Solutions |
Saline Solution, Hypertonic Capillary leak Inflammation Mediators |
Great Vessels Transposition Heart Septal Defects Anticoagulants Heart Diseases Cardiovascular Abnormalities Endocardial Cushion Defects Inflammation Transposition of Great Vessels |
Heart Septal Defects, Ventricular Ventricular Septal Defects Congenital Heart Septum Defect Plasma Substitutes Congenital Abnormalities Heart Defects, Congenital Transposition of Great Arteries Dextrans |
Heart Septal Defects Heart Diseases Anticoagulants Cardiovascular Abnormalities Hematologic Agents Endocardial Cushion Defects Pharmacologic Actions Transposition of Great Vessels |
Heart Septal Defects, Ventricular Therapeutic Uses Blood Substitutes Cardiovascular Diseases Plasma Substitutes Congenital Abnormalities Heart Defects, Congenital Dextrans |