Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Heart Defects, Congenital Clinical Trial

Official title: The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Endocardial Cushion Defects
• Heart Defects, Congenital
• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Transposition of Great Vessels

• NCT number: NCT00199771
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Completed
• Phase: Phase 2
• Start date: June 2003
• Completion date: February 2005