Hypertonic Saline Dextran in Pediatric Cardiac Surgery
Primary Purpose
Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
7.5% NaCl in 6% dextran 70 solution
Sponsored by
About this trial
This is an interventional treatment trial for Heart Defects, Congenital focused on measuring Cardiac Surgery, Infant, Infant, Newborn, Hypertonic Solutions, Saline Solution, Hypertonic, Capillary leak, Inflammation Mediators
Eligibility Criteria
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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00199771
First Posted
September 13, 2005
Last Updated
June 30, 2011
Sponsor
Oslo University Hospital
Collaborators
BioPhausia
1. Study Identification
Unique Protocol Identification Number
NCT00199771
Brief Title
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
Official Title
The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
BioPhausia
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular, Endocardial Cushion Defects
Keywords
Cardiac Surgery, Infant, Infant, Newborn, Hypertonic Solutions, Saline Solution, Hypertonic, Capillary leak, Inflammation Mediators
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
14 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
7.5% NaCl in 6% dextran 70 solution
Primary Outcome Measure Information:
Title
IL-6 and IL-8 2 hours post CPB
Title
Extra vascular lung water 2 and 24 hours post CPB
Secondary Outcome Measure Information:
Title
Fluid balance
Title
Weight gain
Title
Cardiac output
Title
Intrathorasic blood volume
Title
Blood pressure during the first 24 hours post CPB
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Bentsen, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Hypertonic Saline Dextran in Pediatric Cardiac Surgery
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