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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23984
Enrollment
50
Registered
2021-10-27
Start date
2021-10-27
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cyanotic, left to right shunt congenital heart disease

Interventions

None

Sponsors

UMCG
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactC Niezen

University Medical Center Groningen

c.k.niezen@umcg.nl0503616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)