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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
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

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

undefined - 16 Weeks (Child)All SexesDoes not accept 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

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

    First Posted
    September 13, 2005
    Last Updated
    June 30, 2011
    Sponsor
    Oslo University Hospital
    Collaborators
    BioPhausia
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    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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