Trial Outcomes & Findings for Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery (NCT NCT01245595)

NCT ID: NCT01245595

Last Updated: 2015-06-08

Results Overview

Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 144 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2015-06-08

Participant Flow

Participant milestones

Measure	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	Placebo Normal Saline Placebo Placebo: Normal Saline
Overall Study STARTED	72	72
Overall Study Completed Full Course of Study Drug	57	61
Overall Study COMPLETED	72	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Baseline characteristics by cohort

Measure	Aminophylline n=72 Participants 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	Placebo n=72 Participants Normal Saline Placebo Placebo: Normal Saline	Total n=144 Participants Total of all reporting groups
Age, Continuous	154 days n=5 Participants	165 days n=7 Participants	155 days n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	72 participants n=7 Participants	144 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Aminophylline n=72 Participants Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours	Placebo n=72 Participants Normal Saline Placebo Placebo: Normal Saline
Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria	43 participants	36 participants

Adverse Events

Aminophylline

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aminophylline n=72 participants at risk 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	Placebo n=72 participants at risk Normal Saline Placebo Placebo: Normal Saline
Cardiac disorders Low Cardiac Output requiring Cardiopulmonary resuscitation or Extracorporeal Membrane Oxygenation	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Cardiac Arrhythmia Leading to Cardiopulmonary Resuscitation	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.

Other adverse events

Measure	Aminophylline n=72 participants at risk 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	Placebo n=72 participants at risk Normal Saline Placebo Placebo: Normal Saline
Cardiac disorders Accelerated Junctional Rhythm	2.8% 2/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Junctional Ectopic Tachycardia	5.6% 4/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	2.8% 2/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Ventricular Tachycardia	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Ectopic Atrial Tachycardia	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	2.8% 2/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Sinus Tachycardia	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Unspecified Tachycardia	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Renal and urinary disorders Acute Kidney Injury (AKI)	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Cardiac disorders Pulmonary Hypertension with low cardiac output	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Blood and lymphatic system disorders Bleeding	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Infections and infestations sepsis	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.
Musculoskeletal and connective tissue disorders Arm and jaw pain	0.00% 0/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.	1.4% 1/72 • Data were collected over the first five postoperative hospital days. Systematic Assessment: each patient was evaluated daily for an adverse event.

Additional Information

Dr. David M. Axelrod

Stanford University Medical Center

Phone: 650-723-7913

Email: daxelrod@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place