Congenital Heart DiseaseNCT01849120
NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery
An observational study of Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- EQUANOX Advance 8004CB sensor
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric cardiac surgical patients that required cardiopulmonary bypass
Who may be able to join
- pediatric patients 0-3 years of age
- scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects
Who cannot join
- weight < 2 kg or > 20 kg
- greater than 3 years of age
- thrombosed femoral arteries
- prior fasciotomies
- currently on extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?
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.
- Conditions
- Congenital Heart Disease
- Being tested
- EQUANOX Advance 8004CB sensor
- Keywords
- near infrared spectroscopy (NIRS), EQUANOX Advance 8004CB probes, cerebral vascular circulation, peripheral perfusion
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUANOX Advance 8004CB sensorDevice
The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: EQUANOX Advance 8004CB sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous lactate level
Measured: 48 hours post surgery
Secondary outcomes (1)
Blood oxygen saturation level
Oxygen saturation level will be measured by near-infrared spectroscopy (NIRS).
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Nonin Medical, Inc
- Responsible party
- Principal investigator, William C. Oliver, Mayo Clinic
- Investigators
- William Oliver, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849120
- Sponsor's protocol ID
- 12-003690
- Status last verified
- Apr 2017
- First submitted
- 6 May 2013
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?
- ClinicalTrials.gov ID
- NCT01849120
- Acronym / sponsor ID
- 12-003690
- Conditions
- Congenital Heart Disease
- Keywords
- near infrared spectroscopy (NIRS), EQUANOX Advance 8004CB probes, cerebral vascular circulation, peripheral perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Nonin Medical, Inc
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near-infrared spectroscopy (NIRS) | – | Device: EQUANOX Advance 8004CB sensorAfter cardiac surgery, all subjects will have EQUANOX Advance 8004CB sensors applied to peripheral sites (left and right calf and side of abdomen). |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric cardiac surgical patients that required cardiopulmonary bypass
Key inclusion criteria (2 listed)
- pediatric patients 0-3 years of age
- scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects
Key exclusion criteria (5 listed)
- weight < 2 kg or > 20 kg
- greater than 3 years of age
- thrombosed femoral arteries
- prior fasciotomies
- currently on extracorporeal membrane oxygenation (ECMO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQUANOX Advance 8004CB sensorThe EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery. | Device | Near-infrared spectroscopy (NIRS) |
Primary outcome
Venous lactate level
Time frame: 48 hours post surgery
1 secondary outcome
Blood oxygen saturation level
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Oliver, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous lactate level (time frame: 48 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.