Status:
COMPLETED
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
BioPhausia
Conditions:
Heart Defects, Congenital
Transposition of Great Vessels
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE2
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 chi...
Detailed 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 surge...
Eligibility Criteria
Inclusion
- Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
- Age below 17 weeks
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00199771
Start Date
June 1 2003
End Date
February 1 2005
Last Update
July 1 2011
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