Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199771

Collaborator

BioPhausia (Industry)

Enrollment

20.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 2

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 Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

IL-6 and IL-8 2 hours post CPB []
Extra vascular lung water 2 and 24 hours post CPB []

Secondary Outcome Measures

Fluid balance []
Weight gain []
Cardiac output []
Intrathorasic blood volume []
Blood pressure during the first 24 hours post CPB []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 16 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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