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se of intraoperative cerebral and renal region Near infrared spectroscopy to predict postoperative outcome; a prospective observational study

Recruiting
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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.
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