Clinical trial NCT01849120: NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery
Official title: Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: near infrared spectroscopy (NIRS)
EQUANOX Advance 8004CB probes
cerebral vascular circulation
peripheral perfusion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Nonin Medical, Inc
First posted: 2013-05-08
Enrollment: 35
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric cardiac surgical patients that required cardiopulmonary bypass

Brief summary: Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is LCOS that is responsible for the majority of early postoperative deaths in this population of neonates and infants. Improved pediatric probes placed in peripheral locations using near infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations reflecting overall perfusion and oxygen balance in the tissues. Following parental or guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart disease will be enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be placed on the flank, lower extremities and the forehead. Continuous NIRS saturations will be monitored and stored for analysis. Point of care (POC) lactates will be obtained after admission to the intensive care unit (ICU) every 2 hours for the first 24 hours postoperatively, then once at 48 hours. The association between NIRS oxygen saturation and POC lactate values will be assessed using mixed linear models taking into account the repeated measures design. Exploratory analyses will be performed to assess whether NIRS oxygen saturation is associated with outcomes such as days in ICU, adverse events and mortality.

The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac output will allow better and earlier therapy for neonates and infants following cardiac surgery.


Eligibility criteria: Inclusion:

* pediatric patients 0-3 years of age
* scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects

Exclusion:

* weight \< 2 kg or \> 20 kg
* greater than 3 years of age
* thrombosed femoral arteries
* prior fasciotomies
* currently on extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: Venous lactate level
timeFrame: 48 hours post surgery
Secondary outcomes:
measure: Blood oxygen saturation level
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William Oliver, MD
role: PRINCIPAL_INVESTIGATOR
References: