Recruiting
Phase 3

Observational Study

Sponsor:

Le Bonheur Children's Hospital

Code:

NCT03897335

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Aminophylline

Placebo

Study Details

Brief summary:

The purpose of this study is to compare the effects of peri-operative administration of Aminophylline versus Saline placebo in the preservation of renal function and the attenuation of renal injury in pediatric patients undergoing open heart surgery.

Conditions

Acute Kidney Injury

Study ID

NCT03897335

Start date

Feb 7, 2019

Status verified date

Apr, 2022

Completion date

Feb 1, 2024

Anticipated

Primary completion date

Feb 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.
  • Patients ≤ 18 years of age
  • Congenital heart defects
  • Cardiomyopathy (Dilated/Hypertrophic/Restrictive/Left Ventricular Non-compaction)

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Aminophylline pre CPB & immediately post CPB

placebo comparator: Placebo

Interventions

Aminophylline

Aminophylline pre cardiopulmonary bypass and immediately post cardiopulmonary bypass. The dose will be Aminophylline 5 mg/kg/dose, max 350 mg slow infusion. The infusion rate duration will be standardized to 20 minutes. There will be no other aminophylline treatments for the first post-op five days.

Placebo

The placebo group will not receive any aminophylline treatments for the first post-op five days

Primary outcome measure

  • Acute kidney injury state II/III by AKIN criteria [ Time Frame: At 48 hours post-operative ]

Central Contacts and Locations

Central contacts

Lauren Davis

901-287-4594lauren.davis2@lebonheur.org

Kerry Moore, RN

901-287-6871kerry.moore@lebonheur.org

Locations

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Lauren Davis

901-287-4594lauren.davis2@lebonheur.org

Kerry Moore, RN

901-287-6871kerry.moore@lebonheur.org

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Umar S Boston, MD

901-287-5958uboston@uthsc.edu

Kerry Moore, RN

901-287-6871kerry.moore@lebonheur.org

More Information

Sponsor

Le Bonheur Children's Hospital

Last update posted

Apr 18, 2022

Last verified

Apr, 2022

Keywords

  • Aminophylline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Le Bonheur Children's Hospital on 2022-04-18.