Preventing Acute Kidney Injury (AKI) in Neonates

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is compare the effects of peri-operative administration of aminophylline (non-specific adenosine receptor antagonist) versus saline placebo in the preservation of renal function and the attenuation of renal injury in newborns, and young infants following cardiac palliative/correction surgery.

The study rationale is Aminophylline and theophylline are competitive non-selective inhibitors of adenosine. Therefore, even though aminophylline infusion (iv) has no effect on renal blood flow rate at baseline, it can ameliorate the decrease in renal blood flow rate following adenosine infusion. This property can improve renal function when the main mechanism of insult induces vasoconstriction. Both early and late administration of aminophylline protects renal function after ischemia-reperfusion injury in rats. Aminophylline has also been reported to successfully reverse newborn renal failure, prevent renal failure in perinatal asphyxia, and reverse acute kidney injury secondary to calcineurin induced nephropathy. Both theophylline and aminophylline have been used for prophylaxis of renal impairment during aorto-coronary bypass surgery in adults and the results have not been consistent for either a positive or negative effect. There have been no trials reported on the effect of aminophylline or theophylline to prevent or ameliorate acute kidney injury in children with congenital heart defects going through cardiac surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Le Bonheur Children's Hospital
• Treatments: Aminophylline

Criteria

Inclusion Criteria:

Cohort 1

° All children undergoing open heart surgery for congenital heart defects with or

without circulatory arrest

• Neonates (<28 days old) and infants (<1 years of age)

• Hypoplastic L heart syndrome or its variants.

• Coarctation with aortic arch hypoplasia.

• Interrupted aortic arch.

• TAPVR (Total anomalous pulmonary venous return)

• Patients with complex congenital heart defects

Cohort 2:

• Orthotopic heart transplantation patients.

• Congenital heart defects

• Cardiomyopathy (Dilated/ hypertrophic)

Exclusion Criteria:

• Children under the age of 12 months undergoing bypass for any condition that is not categorized as congenital heart defect

• History of seizures

• History of significant tachyarrhythmia.