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Hypertonic Saline Dextran in Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199771
First Posted: September 20, 2005
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BioPhausia
Information provided by:
Oslo University Hospital
  Purpose
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.

Condition Intervention Phase
Heart Defects, Congenital Transposition of Great Vessels Heart Septal Defects, Ventricular Endocardial Cushion Defects Drug: 7.5% NaCl in 6% dextran 70 solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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

Estimated Enrollment: 14
Study Start Date: June 2003
Study Completion Date: February 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   up to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199771


Sponsors and Collaborators
Oslo University Hospital
BioPhausia
Investigators
Principal Investigator: Gunnar Bentsen, MD Oslo University Hospital
  More Information

Responsible Party: Gunnar Bentsen / Consultant, Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00199771     History of Changes
Other Study ID Numbers: 2003-HSD
S-01003 (ethics committee)
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: July 1, 2011
Last Verified: January 2008

Keywords provided by Oslo University Hospital:
Cardiac Surgery
Infant
Infant, Newborn
Hypertonic Solutions
Saline Solution, Hypertonic
Capillary leak
Inflammation Mediators

Additional relevant MeSH terms:
Endocardial Cushion Defects
Heart Septal Defects
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Ventricular
Transposition of Great Vessels
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Pharmaceutical Solutions
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes