Heart Defects, Congenital, Respiratory Insufficiency
Conditions
Keywords
Heart Defects, Congenital, Extracorporeal Membrane Oxygenation, Citric Acid, Heparin, Respiratory Insufficiency
Brief summary
The purpose of this study is to determine the safety and efficacy of citrate to provide anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the patient and increases the risk of patient bleeding.
Detailed description
Extracorporeal membrane oxygenation (ECMO) is a form of extended heart/lung bypass support that has been used to treat more than 650 patients over 20 years at Vanderbilt. Over 29,000 patients have been treated worldwide. Bleeding is the most common complication during ECMO because of systemic anticoagulation with heparin. It is most commonly seen in patients following surgery either preceding or while on ECMO support. Regional citrate anticoagulation for hemodialysis was first introduced in 1961. It is the ideal alternative to heparin in patients who are at increased risk for bleeding. It permits effective anticoagulation across the extracorporeal circuit without impacting the patient's systemic coagulation. Citrate functions by binding free calcium, thereby inhibiting coagulation in both the intrinsic and extrinsic coagulation pathways. The purpose of this study is to evaluate the use of citrate as a regional anticoagulant in the ECMO circuit in high risk infants less than one year of age.
Interventions
DRUGsodium citrate
Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* Infant less than one year of age and less than 6 kg * Informed consent obtained from parent * One or more of the following diagnoses: * Post-op congenital heart surgery * Congenital diaphragmatic hernia * Sepsis with coagulopathy not corrected prior to ECMO * Other newborn diagnosis with Grade I or II IVH * Infant requires/is on ECMO
Exclusion criteria
* Consent denied or unobtainable * Age greater than one year * Weight greater than 6 kg * Gestational age less than 34 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient | hourly |
Secondary
| Measure | Time frame |
|---|---|
| Maintain normal serum calcium levels in patients | hourly |
Countries
United States
Outcome results
None listed