Trial | NCT00199771  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
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.
Study Started
Jun 30
2003
Primary Completion
Dec 31
2004
Study Completion
Feb 28
2005
Last Update
Jul 01
2011
Estimate

Drug 7.5% NaCl in 6% dextran 70 solution

Criteria 

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
No Results Posted