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Clinical Trials/NL-OMON23984
NL-OMON23984
Recruiting
Not Applicable

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

MCG0 sites50 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on-cyanotic, left to right shunt congenital heart disease
Sponsor
MCG
Enrollment
50
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
MCG

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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