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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mayo Clinic
Sponsor:
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01849120
First received: May 6, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Device: EQUANOX Advance 8004CB sensor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Venous lactate level [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood oxygen saturation level [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Oxygen saturation level will be measured by near-infrared spectroscopy (NIRS).


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Near-infrared spectroscopy (NIRS)
After cardiac surgery, all subjects will have EQUANOX Advance 8004CB sensors applied to peripheral sites (left and right calf and side of abdomen).
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.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849120

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: De Anna Haugen    507-255-3724    haugen.deanna@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Nonin Medical, Inc
Investigators
Principal Investigator: William Oliver, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: William C. Oliver, William Oliver, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01849120     History of Changes
Other Study ID Numbers: 12-003690
Study First Received: May 6, 2013
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
near infrared spectroscopy (NIRS)
EQUANOX Advance 8004CB probes
cerebral vascular circulation
peripheral perfusion

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014