Hypertonic Saline Dextran in Pediatric Cardiac Surgery

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. Identifier: NCT00199771
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 1, 2011
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 14 participants
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.
Study Start Date : June 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : February 2005

Primary Outcome Measures :
  1. IL-6 and IL-8 2 hours post CPB
  2. Extra vascular lung water 2 and 24 hours post CPB

Secondary Outcome Measures :
  1. Fluid balance
  2. Weight gain
  3. Cardiac output
  4. Intrathorasic blood volume
  5. Blood pressure during the first 24 hours post CPB

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Ages Eligible for Study:   up to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00199771

Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Gunnar Bentsen, MD Oslo University Hospital

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

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

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