Acute Kidney Injury
Conditions
Keywords
Acute Kidney Injury (AKI), Cardiopulmonary bypass (CPB)
Brief summary
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the heart-lung machine). Approximately 35 to 50% of these children will have acute kidney injury, or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.
Detailed description
Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.
Interventions
DRUGAminophylline
5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
DRUGPlacebo
Normal Saline
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Less than 18 years old, undergoing cardiac surgery with bypass * neonates must be at least 36 weeks gestational age
Exclusion criteria
* History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria | 5 days | Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aminophylline Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours | 72 |
| Placebo Normal Saline Placebo
Placebo: Normal Saline | 72 |
| Total | 144 |
Baseline characteristics
| Characteristic | Aminophylline | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 154 days | 165 days | 155 days |
| Region of Enrollment United States | 72 participants | 72 participants | 144 participants |
| Sex: Female, Male Female | 33 Participants | 30 Participants | 63 Participants |
| Sex: Female, Male Male | 39 Participants | 42 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 72 | 11 / 72 |
| serious Total, serious adverse events | 1 / 72 | 2 / 72 |
Outcome results
Primary
Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria
Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aminophylline | Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria | 43 participants |
| Placebo | Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria | 36 participants |