Comparison of Hematocrit Levels in Infant Heart Surgery

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006183
First received: August 21, 2000
Last updated: March 6, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35% versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of the great arteries, a malformation of the heart vessels.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Transposition of Great Vessels
Procedure: Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits
Procedure: Thoracic Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Hematocrit Strategy in Infant Heart Surgery

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Serum lactate levels (measured 1 hour after surgery)
  • Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)

Secondary Outcome Measures:
  • Duration of postoperative endotracheal intubation, ICU stay, and hospital stay
  • PaO2/FiO2 ratio
  • Levels of circulating pro-inflammatory cytokines
  • Percent change in total body water, as estimated by bioelectrical impedance (measured 1 hour after surgery)
  • Tissue release of S-100 protein as a measure of cerebral cellular injury
  • Cerebral hemodynamics and oxygenation, as determined by near infrared spectroscopy (NIRS)
  • Intrinsic cerebral vasoregulation, as measured by NIRS and transcranial Doppler
  • Neurologic factors, as determined by neurologic examination, the MacArthur inventory, and structural and volumetric findings of MRI (measured at age 1 year)

Estimated Enrollment: 120
Study Start Date: July 2000
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The optimal degree of hemodilution during profoundly hypothermic CPB remains controversial, and widely dissimilar hemodilution studies have evolved at centers that perform infant cardiac surgery. HCT, a measurement of the volume of red blood cells, is of interest in cardiopulmonary bypass. Higher HCT levels expose individuals to the risks of microvascular occlusion (blockage in the small blood vessels), while lower HCT levels may critically limit oxygen delivery to the brain and other organs. Preliminary research suggests that higher HCT levels provide superior brain and myocardial protection, but there have not been any studies that report on outcomes after usage of higher versus lower HCT levels.

DESIGN NARRATIVE:

In this single-center, prospective, randomized study, hemodilution to a HCT level of 35% versus 25% will be compared with respect to neurodevelopmental outcome and early postoperative course in infants with congenital heart disease. The first aim of this study will test the hypothesis that hemodilution to a HCT level of 35%, compared to a level of 25%, will be associated with superior central nervous system protection. The primary outcome variable will be developmental outcome at age 1 year, assessed using the Bayley Scales of Infant Development. Secondary outcome variables include the following: 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).

The second aim of this study will test the hypothesis that hemodilution to a HCT level of 35%, compared to a level of 25%, will be associated with better early postoperative cardiovascular status. The primary outcome measure will be serum lactate levels 1 hour after the surgery. Secondary outcome measures will include the following: 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. Through the use of novel techniques such as NIRS and volumetric MRI, the study may also provide insight into mechanisms by which HCT and other perioperative variables affect the brain. The information obtained from this study should be broadly generalized to infants with other forms of congenital heart disease undergoing early repair and should have substantial impact on clinical practice.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing repair of ventricular septal defect within 9 months of study entry
  • Tetralogy of fallot
  • D-transposition of the great arteries
  • Atrio-ventricular septal defect

Exclusion Criteria:

  • Birth weight less than 2.3 kg
  • Recognizable phenotypic syndrome of congenital anomalies
  • Extracardiac anomalies of greater than minor severity
  • Previous cardiac surgery
  • Associated cardiovascular anomalies requiring aortic arch reconstruction or additional open surgical procedures before the planned developmental follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006183

Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Study Chair: Jane W. Newburger, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jane. W. Newburger, M.D., Principal Investigator, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00006183     History of Changes
Other Study ID Numbers: 131, U01 HL63411
Study First Received: August 21, 2000
Last Updated: March 6, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Diseases
Heart Defects, Congenital
Heart Diseases
Transposition of Great Vessels
Cardiovascular Abnormalities

ClinicalTrials.gov processed this record on July 26, 2014