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Methylxanthine

Aminophylline for Preventing Acute Kidney Injury in Children (AKI Trial)

Q: What are the dangers of taking Aminophylline before and after surgery?

<p>Aminophylline pre CPB &#x26; immediately post CPB is a Phase 3 trial medication, meaning that there is both available efficacy data as well as multiple rounds of safety data. This makes it a relatively safe option, and it received a score of 3 from our team at Power.</p>

Phase 3

Waitlist Available

Research Sponsored by Le Bonheur Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up max point within post cpb 72 hours

Awards & highlights

AKI Trial Summary

This trial is testing whether giving the drug aminophylline to kids before open heart surgery will help preserve kidney function and reduce renal injury.

Who is the study for?

This trial is for children undergoing open heart surgery for congenital heart defects, including neonates and infants with specific conditions like hypoplastic left heart syndrome. It's also for patients up to 18 years old needing a heart transplant due to defects or cardiomyopathy. Kids under 12 months without congenital heart defects, those with seizure history, or significant tachyarrhythmia can't participate.Check my eligibility

What is being tested?

The study tests if Aminophylline can better preserve kidney function compared to a saline placebo in pediatric patients having open-heart surgery. The goal is to see if it reduces the risk of acute kidney injury by comparing two groups: one receiving Aminophylline and the other a placebo.See study design

What are the potential side effects?

Aminophylline may cause side effects such as nausea, vomiting, diarrhea, irritability, restlessness or trouble sleeping. In some cases, it might lead to abnormal heartbeat rhythms or seizures especially in high doses.

AKI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ max point within post cpb 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~max point within post cpb 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and max point within post cpb 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute kidney injury state II/III by AKIN criteria

Secondary outcome measures

Kidney Failure, Acute

Concentration of Delta serum cystatin C

Urine output during post op

Other outcome measures

Concentration of Delta urinary neutrophil gelatinase-associated lipocalin (NGAL)

Dialysis requirement (yes/no)

Duration of hospital stay (Days).

+7 more

AKI Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Aminophylline pre CPB & immediately post CPBActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Le Bonheur Children's HospitalLead Sponsor

27 Previous Clinical Trials

5,020,969 Total Patients Enrolled

Media Library

Aminophylline (Methylxanthine) Clinical Trial Eligibility Overview. Trial Name: NCT03897335 — Phase 3

Acute Kidney Injury Research Study Groups: Aminophylline pre CPB & immediately post CPB, Placebo

Acute Kidney Injury Clinical Trial 2023: Aminophylline Highlights & Side Effects. Trial Name: NCT03897335 — Phase 3

Aminophylline (Methylxanthine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03897335 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Aminophylline given to patients before and after cardiac surgery for?

"Aminophylline is most often given to patients before and after surgery to correct a lung disorder. However, it has also been used effectively to treat bronchitis, bronchospasm, and asthma."

Answered by AI

Are patients being actively recruited for this study at this time?

"That is correct, the listing on clinicaltrials.gov notes that this research trial is currently seeking participants. This study was originally posted on February 7th, 2019 and was last updated on April 11th, 2022. A total of 80 individuals are required across 1 site."

Answered by AI

What are the dangers of taking Aminophylline before and after surgery?

"Aminophylline pre CPB & immediately post CPB is a Phase 3 trial medication, meaning that there is both available efficacy data as well as multiple rounds of safety data. This makes it a relatively safe option, and it received a score of 3 from our team at Power."

Answered by AI

How many people are total are expected to join this trial?

"Yes, according to the latest information on clinicaltrials.gov, this study is still looking for participants. The listing was first posted on February 7th, 2019 and was last updated on April 11th, 2022. They are hoping to find 80 individuals total at 1 location."

Answered by AI

Could you please share any other instances where Aminophylline has been studied in patients before and after surgery?

"Currently, there are 3 ongoing clinical trials for Aminophylline pre CPB & immediately post CPB with 1 in Phase 3. Most of these research projects are based in Memphis, but there are also 2 other locations running similar investigations."

Answered by AI

Recent research and studies

Kidney InternationalJournal

Early Initiation of Peritoneal Dialysis in Neonates and Infants with Acute Kidney Injury Following Cardiac Surgery Is Associated with a Significant Decrease in Mortality

Bojan, Mirela, Simone Gioanni, Pascal R. Vouhé, Didier Journois, and Philippe Pouard. 2012. “Early Initiation of Peritoneal Dialysis in Neonates and Infants with Acute Kidney Injury Following Cardiac Surgery Is Associated with a Significant Decrease in Mortality”. Kidney International. Elsevier BV. doi:10.1038/ki.2012.172.

Archives of Disease in ChildhoodJournal

Acute Renal Failure Complicating Cardiopulmonary Bypass Surgery.

Rigden, S P, T M Barratt, M J Dillon, M De Leval, and J Stark. 1982. “Acute Renal Failure Complicating Cardiopulmonary Bypass Surgery.”. Archives of Disease in Childhood. BMJ. doi:10.1136/adc.57.6.425.

The Journal of Thoracic and Cardiovascular SurgeryJournal

Congenital Heart Surgery in Infants: Effects of Acute Kidney Injury on Outcomes

Blinder, Joshua J., Stuart L. Goldstein, Vei-Vei Lee, Alixandra Baycroft, Charles D. Fraser, David Nelson, and John L. Jefferies. 2012. “Congenital Heart Surgery in Infants: Effects of Acute Kidney Injury on Outcomes”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2011.06.021.

American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyJournal