NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849120
• Other study ID #: 12-003690
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: April 12, 2017
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Output, Low
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• EQUANOX Advance 8004CB sensor
The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous lactate level		48 hours post surgery
Secondary	Blood oxygen saturation level	Oxygen saturation level will be measured by near-infrared spectroscopy (NIRS).	48 hours after surgery