Comparison of Hematocrit Levels in Infant Heart Surgery

Cardiovascular Diseases Clinical Trial

Official title:

Hematocrit Strategy in Infant Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006183
• Other study ID #: 131
• Secondary ID: U01HL063411
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2000
• Last updated: July 28, 2016
• Start date: July 2000
• Est. completion date: July 2005

Study information

• Verified date: March 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Transposition of Great Vessels

Intervention

Procedure:
• Cardiopulmonary Bypass with Two Different Intra-Operative Hematocrits

• Thoracic Surgery

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bassan H, Gauvreau K, Newburger JW, Tsuji M, Limperopoulos C, Soul JS, Walter G, Laussen PC, Jonas RA, du Plessis AJ. Identification of pressure passive cerebral perfusion and its mediators after infant cardiac surgery. Pediatr Res. 2005 Jan;57(1):35-41. Epub 2004 Nov 5. — View Citation

Jonas RA, Wypij D, Roth SJ, Bellinger DC, Visconti KJ, du Plessis AJ, Goodkin H, Laussen PC, Farrell DM, Bartlett J, McGrath E, Rappaport LJ, Bacha EA, Forbess JM, del Nido PJ, Mayer JE Jr, Newburger JW. The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: results of a randomized trial in infants. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1765-74. — View Citation

Kussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-300. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lactate levels (measured 1 hour after surgery)
Primary	Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)
Secondary	Duration of postoperative endotracheal intubation, ICU stay, and hospital stay
Secondary	PaO2/FiO2 ratio
Secondary	Levels of circulating pro-inflammatory cytokines
Secondary	Percent change in total body water, as estimated by bioelectrical impedance (measured 1 hour after surgery)
Secondary	Tissue release of S-100 protein as a measure of cerebral cellular injury
Secondary	Cerebral hemodynamics and oxygenation, as determined by near infrared spectroscopy (NIRS)
Secondary	Intrinsic cerebral vasoregulation, as measured by NIRS and transcranial Doppler
Secondary	Neurologic factors, as determined by neurologic examination, the MacArthur inventory, and structural and volumetric findings of MRI (measured at age 1 year)