Hypertonic Saline Dextran in Pediatric Cardiac Surgery

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199771

Enrollment

Registered

2005-09-20

Start date

2003-06-30

Completion date

2005-02-28

Last updated

2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiac Surgery, Infant, Infant, Newborn, Hypertonic Solutions, Saline Solution, Hypertonic, Capillary leak, Inflammation Mediators

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.

Interventions

DRUG7.5% NaCl in 6% dextran 70 solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Weeks

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

Design outcomes

Primary

Measure	Time frame
IL-6 and IL-8 2 hours post CPB	—
Extra vascular lung water 2 and 24 hours post CPB	—

Secondary

Measure	Time frame
Cardiac output	—
Fluid balance	—
Blood pressure during the first 24 hours post CPB	—
Intrathorasic blood volume	—
Weight gain	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026