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Hypertonic Saline Dextran in Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
BioPhausia
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00199771
First received: September 13, 2005
Last updated: June 30, 2011
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 16 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199771

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

No publications provided

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)
Study First Received: September 13, 2005
Last Updated: June 30, 2011
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Congenital Abnormalities
Endocardial Cushion Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Heart Septal Defects
Transposition of Great Vessels
Cardiovascular Abnormalities
Cardiovascular Diseases
 Heart Diseases
Dextrans
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on May 23, 2013