Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Phase 2CompletedNCT00199771

Oslo University Hospital14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Defects, Congenital Transposition of Great Vessels Heart Septal Defects, Ventricular Endocardial Cushion Defects

Interventions

7.5% NaCl in 6% dextran 70 solutionDRUG

Eligibility

Sex: ALLMax age: 16 Weeks

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.