The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Primary Endpoint
- IL-6 and IL-8 2 hours post CPB
Study Overview
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 children.
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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- — to 16 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
IL-6 and IL-8 2 hours post CPB
Extra vascular lung water 2 and 24 hours post CPB
Secondary Outcomes
- Fluid balance
- Weight gain
- Cardiac output
- Intrathorasic blood volume
- Blood pressure during the first 24 hours post CPB