Hypertonic Saline Dextran in Pediatric Cardiac Surgery

University of Oslo (UIO)

Status and phase

Completed

Phase 2

Conditions

Heart Defects, Congenital

Endocardial Cushion Defects

Heart Septal Defects, Ventricular

Transposition of Great Vessels

Treatments

Drug: 7.5% NaCl in 6% dextran 70 solution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00199771

2003-HSD

S-01003 (ethics committee)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 16 weeks old

Volunteers

No 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