Clinical trial NCT00451698: Erythropoietin and Pediatric Cardiac Surgery
Official title: Erythropoietin and Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Congenital Heart Defect
Keywords: Erythropoietin
Congenital heart surgery
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
name: National Center for Research Resources (NCRR)
First posted: 2007-03-23
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Detailed description: Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. A medicine already used in humans, erythropoietin, may protect the heart and brain of children born with heart defects during their surgical repair. In a rabbit model, erythropoietin did protect the hearts. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury.

For this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects, will be divided into four groups. Two groups will be children whose usual blood oxygen level is low because of their heart defect; the other two will be children with normal blood oxygen levels. Each child will be randomized to receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their surgery.

Erythropoietin's protective function will be measured after surgery by: (1) amount of medication required to support heart function, (2) how well the heart pumps blood as seen by echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) ICU stay and (7) hospital stay. Heart tissue will be collected during surgery to determine how erythropoietin protects heart cells.

Statistical tests including ANOVA will test for similarities and differences among the groups on the measures of protection from injury.

Note - the study design was edited after the FDA released a warning about the use of erythropoietin. Only acyanotic patients were recruited therefore only 2 study groups are included.

Eligibility criteria: Inclusion Criteria:

* Age 6 weeks to 18 years
* Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

Exclusion Criteria:

* Received erythropoietin within past 30 days
* Previous adverse reaction to erythropoietin or to albumin
* History of neurological disorder -Laboratory evidence of kidney or liver dysfunction -

Primary outcomes:
measure: Biochemical Markers of Heart Damage
timeFrame: 4 postoperative time points up to 48 hours
measure: Biochemical Markers of Neuron Damage
timeFrame: 4 postoperative time points
measure: Echocardiographic Assessment of Heart Function
timeFrame: 24 hours postop
Secondary outcomes:
measure: Inotropic Support
timeFrame: 24 and 48 hours post operative
measure: Length of Hospitalization
timeFrame: At hospital discharge, up to 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Steve Zangwill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: John Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi Y, Rafiee P, Su J, Pritchard KA Jr, Tweddell JS, Baker JE. Acute cardioprotective effects of erythropoietin in infant rabbits are mediated by activation of protein kinases and potassium channels. Basic Res Cardiol. 2004 May;99(3):173-82. doi: 10.1007/s00395-004-0455-x. Epub 2004 Jan 29.