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ID
Source
Brief title
Health condition
Non-cyanotic, left to right shunt congenital heart disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
We would also like to determine which deviation from baseline NIRS values give the clinician the information to redirect intra-operative care.
Background summary
Background: Postoperative acute kidney injury (AKI) is a frequent complication after cardiac surgery in pediatric patients, ranging from 20 to 86% depending on the population and used definition of AKI. The diagnosis of renal injury is commonly based on creatinine elevation, but this biomarker only increases when an extensive kidney injury has already developed. Literature advises using the KDIGO criteria (combination of serum creatinine values and urine output) to assess the degree of AKI. Since renal hypoperfusion and hypoxia are among the most important insults contributing to postoperative AKI, near-infrared spectroscopy (NIRS), measuring regional tissue saturation (StO2) might prove useful in the real-time detection of renal tissue hypoxia, alerting the clinician to redirect care to prevent a potential ischemic insult and kidney injury.
Main research question: We aim to determine whether cerebral NIRS or renal region NIRS could predict the postoperative incidence of AKI.
Design (including population, confounders/outcomes): Prospective observational pilot study, this is a non-WMO study. The population is infants and children below 18 years of age with non-cyanotic with a left to right shunt congenital heart disease. The outcome is postoperative AKI, defined using the KDIGO criteria (blood creatinine and urine output).
Study objective
We hypothesize that lower renal region or cerebral NIRS values are correlated with a higher incidence of postoperative AKI in this study population
Study design
Multiple; Continuous monitoring intraoperative
Intervention
None
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9852 |
| Other | METC UMCG : METc 2021/191 |