NIRS Guidance Trail in Children's Heart Surgery
Completed · Not applicable
Conditions studied: Heart Defects, Congenital
In brief
Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA). The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.
Key facts
- Study ID
- NCT02157597
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 73
- Starts
- 2011-11-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-05-12
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- undergoing elective or emergency heart surgery
- under 6 months of age
- operation requiring cardiopulmonary bypass
- complex operation, defined as RACH-1 score 3 to 6 inclusive
You may not qualify if…
- weight less than 2 kg
- prematurity defined as less than or equal to 36 weeks post-concepional age at tme of operation
- preoperative renal failure defined as serum creatinine greater than 132 mmol/l
- major non-cardiac congenital anomalies or preoperative non-cardiac disease
- operation or any of its components not classified in the RACHS-1 system
- receiving preoperative mechanical circulatory support
- presence of known intracranial hematomas or cerebral arteriovenous malformations
- reoperation if previously enrolled
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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