Comparison of Hematocrit Levels in Infant Heart Surgery

July 28, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Hematocrit Strategy in Infant Heart Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

August 21, 2000

First Submitted That Met QC Criteria

August 21, 2000

First Posted (Estimate)

August 22, 2000

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131 (Tumor Vaccine Group)
  • U01HL063411 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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