se of intraoperative cerebral and renal region Near infrared spectroscopy to predict postoperative outcome; a prospective observational study
- Conditions
- on-cyanotic, left to right shunt congenital heart disease
- Registration Number
- NL-OMON23984
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Infants and children (0-18 years)
Undergoing elective cardiac surgery with cardiopulmonary bypass for correction of non-cyanotic, left to right shunt congenital heart disease
Pre-existing renal disease (mentioned in the patient history or preoperative serum creatinine >100 µmol/L)
Structural renal diseases/abnormalities
Pre-existing cerebral disease (mentioned in the patient history)
Limitations in the positioning of NIRS sensors (for example skin defects or diathermia pad placement)
Extreme prematurity (gestational age <32 weeks)
Known or suspected allergies to glue of the adhesive NIRS sensors
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to determine if cerebral NIRS values and renal region NIRS values are predictors for postoperative AKI in infants with non-cyanotic, left to right shunt congenital heart disease.
- Secondary Outcome Measures
Name Time Method We would like to determine if cerebral NIRS and regional region NIRS are correlated, which lets us determine if we only need to use 1 sensor spot placement in the future.<br>We would also like to determine which deviation from baseline NIRS values give the clinician the information to redirect intra-operative care.