Hypertonic Saline Dextran in Pediatric Cardiac Surgery - Full Text View

Sponsor:	Rikshospitalet HF
Collaborator:	BioPhausia
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00199771

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Congenital Heart Defects Drinking Water Heart Surgery Surgery

Drug Information available for: Dextrans

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

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

Rikshospitalet HF

BioPhausia

Investigators

Principal Investigator:

Gunnar Bentsen, MD

Rikshospitalet HF

More Information

No publications provided

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Gunnar Bentsen / Consultant )
Study ID Numbers:	2003-HSD, S-01003 (ethics committee)
Study First Received:	September 13, 2005
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00199771 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet HF:

Cardiac Surgery
Infant
Infant, Newborn
Hypertonic Solutions

Saline Solution, Hypertonic
Capillary leak
Inflammation Mediators

Additional relevant MeSH terms:

Heart Septal Defects
Heart Diseases
Anticoagulants
Cardiovascular Abnormalities
Hematologic Agents
Endocardial Cushion Defects
Pharmacologic Actions
Transposition of Great Vessels

Heart Septal Defects, Ventricular
Therapeutic Uses
Blood Substitutes
Cardiovascular Diseases
Plasma Substitutes
Congenital Abnormalities
Heart Defects, Congenital
Dextrans

ClinicalTrials.gov processed this record on February 08, 2010