Hypertonic Saline Dextran in Pediatric Cardiac Surgery

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199771
• Other study ID #: 2003-HSD
• Secondary ID: S-01003 (ethics
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 30, 2011
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: January 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 7.5% NaCl in 6% dextran 70 solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	BioPhausia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6 and IL-8 2 hours post CPB
Primary	Extra vascular lung water 2 and 24 hours post CPB
Secondary	Fluid balance
Secondary	Weight gain
Secondary	Cardiac output
Secondary	Intrathorasic blood volume
Secondary	Blood pressure during the first 24 hours post CPB