Comparison of Hematocrit Levels in Infant Heart Surgery

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Brief Title

Comparison of Hematocrit Levels in Infant Heart Surgery

Official Title

Hematocrit Strategy in Infant Heart Surgery

Brief Summary

      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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Serum lactate levels (measured 1 hour after surgery)

Secondary Outcome

 Duration of postoperative endotracheal intubation, ICU stay, and hospital stay

Condition

Cardiovascular Diseases

Intervention

Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

July 2000

Completion Date

July 2005

Primary Completion Date

July 2005

Eligibility 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
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Jane W. Newburger, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006183

Organization ID

131

Secondary IDs

U01HL063411


Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)


Study Sponsor

Jane W. Newburger, MD, MPH, Study Chair, Children's Hospital Medical Center, Cincinnati


Verification Date

March 2008