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NCT01849120 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Mayo Clinic.

Completed
Registry status
35
Enrollment target

NCT01849120: Completed study, sponsored by Mayo Clinic.

NCT01849120 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01849120 has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
35 participants
Enrollment target

Study 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.

Interventions

  • DEVICE EQUANOX Advance 8004CB sensor

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2013-05
Est. Completion 2015-09
Mayo Clinic

2,844 total trials

What the finished NCT01849120 record still lists

NCT01849120 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which EQUANOX Advance 8004CB sensor is the first listed.

NCT01849120 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01849120 about?

NCT01849120 is a clinical study titled "NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery". 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 ...

What is the current status of trial NCT01849120?

This trial is currently completed. The enrollment target is 35 participants. The study started on 2013-05. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01849120?

The interventions under investigation include: EQUANOX Advance 8004CB sensor (DEVICE).

Who is sponsoring clinical trial NCT01849120?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01849120, the US trial registry maintained by the National Library of Medicine. NCT01849120 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.