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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminophylline | Active Comparator | Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours |
|
| Placebo | Placebo Comparator | Normal Saline Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminophylline | Drug | 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| david m axelrod, md | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Childrens' Hospital | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Normal Saline Placebo Placebo: Normal Saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Normal Saline Placebo Placebo: Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, continuous, Days |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 5 days |
|
Data were collected over the first five postoperative hospital days.
Systematic Assessment: each patient was evaluated daily for an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Cardiac Output requiring Cardiopulmonary resuscitation or Extracorporeal Membrane Oxygenation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accelerated Junctional Rhythm | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David M. Axelrod | Stanford University Medical Center | 650-723-7913 | daxelrod@stanford.edu |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| Placebo | Drug | Normal Saline |
|
| BG002 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 72 |
| 10 |
| 72 |
| EG001 | Placebo | Normal Saline Placebo Placebo: Normal Saline | 2 | 72 | 11 | 72 |
| Cardiac Arrhythmia Leading to Cardiopulmonary Resuscitation | Cardiac disorders | Systematic Assessment |
|
| Junctional Ectopic Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ectopic Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Unspecified Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Acute Kidney Injury (AKI) | Renal and urinary disorders | Systematic Assessment | Managing physician treated AKI with aminophylline out of protocol |
|
| Pulmonary Hypertension with low cardiac output | Cardiac disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| Arm and jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |