Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery

Completed

Conditions studied: Acute Kidney Injury, Heart; Dysfunction Postoperative, Cardiac Surgery, Children

In brief

One in a hundred children is born with a heart defect. Some children require heart surgery within the first few days of life, while others can wait until they are older. A complication of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden loss of kidney function known as acute kidney injury (AKI). AKI causes complications that can increase hospital length of stay and increase risk of death. Current ways to identify AKI are not able to it until 2 or 3 days after it has occurred. Because of this, there is not a specific treatment for AKI. If the investigators diagnose AKI early, they might be able to treat it and improve outcomes in children. NIRS is a skin monitor that can detect low blood flow to the kidney and might help diagnose AKI when it occurs in the operating room. The use of NIRS to diagnose AKI early is the focus of this study.

Key facts

Study ID

NCT01382758

Run by

University of Colorado, Denver

People needed

107

Starts

2011-07-01

Expected to finish

2013-01-01

Last updated by the study team

2013-01-18

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All children less than or equal to age 4 undergoing cardiac surgery with the use of cardiopulmonary bypass at Colorado Children's Hospital

You may not qualify if…

• Prior enrollment in the study
• Agre greater than 4 years
• Use of nephrotoxic drugs within 48 hours of surgery
• Underlying renal dysfunction (preoperative estimated Schwartz clearance less than 80ml/min/1.73m2)
• Gestational age less than 34 weeks at the time of surgery
• Withdrawal of care planned

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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