|
Hematocrit Strategy in Infant Heart Surgery Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Hematocrit Strategy in Infant Heart Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hematocrit Strategy in Infant Heart Surgery Clinical research trials and Hematocrit Strategy in Infant Heart Surgery healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Hematocrit Strategy in Infant Heart Surgery. Hematocrit Strategy in Infant Heart Surgery Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Hematocrit Strategy in Infant Heart Surgery clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Hematocrit Strategy in Infant Heart Surgery condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Hematocrit Strategy in Infant Heart Surgery  Hematocrit Strategy in Infant Heart Surgery
Hematocrit Strategy in Infant Heart Surgery
For Condition: Heart Diseases,Defect, Congenital Heart,Transposition of Great Vessels,Cardiovascular Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To compare hemodilution to a hematocrit of 35 percent versus a hematocrit of 25 percent during hypothermic cardiopulmonary bypass in infants with d-transposition of the great arteries.
Details: BACKGROUND: The optimal degree of hemodilution during profoundly hypothermic cardiopulmonary bypass (CPB) remains controversial, and widely disparate hemodilution protocols have evolved at centers undertaking infant cardiac surgery. Hematocrit (hct), a measurement of the volume of red cells, is of interest in cardiopulmonary bypass. Higher hematocrit exposes patients to the risks of microvascular occlusion, while lower hct may critically limit oxygen delivery to the brain and other organs. Preliminary data suggests that a higher hct provides superior brain and myocardial protection, but no randomized trials of outcome after use of higher vs. lower hct have been reported. DESIGN NARRATIVE: In the single-center, prospective, randomized trial, hemodilution to a hct of 35 percent vs. 25 percent will be compared with respect to neurodevelopmental outcome and early postoperative course in a homogeneous population of infants with congenital heart disease. Specific Aim 1 will test the hypothesis that hemodilution to a hct of 35 percent, compared to 25 percent, will be associated with superior central nervous system protection. The primary outcome variable will be developmental outcome at age 1 year, assessed using a Bayley Scales of Infant Development. Secondary outcome variables include 1) tissue release of S-100 protein as a measure of cerebral cellular injury; 2) cerebral hemodynamics and oxygenation, determined by near infrared spectroscopy (NIRS); 3) intrinsic cerebral vasoregulation, measured by NIRS and transcranial Doppler; and 4) at age 1 year, neurologic examination, the MacArthur inventory, and structural and volumetric findings of magnetic resonance imaging (MRI). Specific Aim 2 will test the hypothesis that hemodilution to a hct of 35 percent, compared to 25 percent, will be associated with better early postoperative cardiovascular status. The primary outcome measure will be serum lactate 1 hour after the surgery. Secondary outcome measures will include 1) the duration of postoperative endotracheal intubation, ICU stay, and hospital stay; 2) serum lactate levels; 3) the PaO2/FiO2 ratio; 4) levels of circulating pro-inflammatory cytokines; and 5) the percent change in total body water, estimated by bioelectrical impedance. The structure of the study will allow assessment of whether 1-year outcomes can be predicted by perioperative variables other than the hct strategies and, through the use of novel techniques such as NIRS and volumetric MRI, may provide insight into mechanisms by which hct and other perioperative variables affect the brain. The inferences reached in this study population should be broadly generalized to infants with other forms of congenital heart disease undergoing early repair and thus should have substantial impact on clinical practice.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: < 9 months undergoing repair of VSD, tetralogy of fallot, d-transposition, and atrio-ventricular septal defect.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneNewburger, , Children's Hospital
Children's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Dr. Newburger 617-355-5427
Additional Information:
Study ID Numbers: 131;
Study Start Date: July 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006183
Other Cardiovascular Diseases Studies:
1. Prevention of Hypertension: A Randomized Trial
2. Congestive Heart Failure Trends in the Elderly 1970-94
3. Home Automatic External Defibrillator Trial -- HAT
4. Epidemiology of Symptomatic Arrhythmias
5. Fat Reduction Intervention Trial in African-Americans
Related Studies:
Other Cardiovascular Diseases Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Hematocrit Strategy in Infant Heart Surgery
|
|
|
|
|
|
|
|
