Preventing Acute Kidney Injury (AKI) in Pediatric Patients

NCT03897335 | Unknown Phase 3 FDA Drug

• 1 other identifier: Acute Kidney Injury
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

Aminophylline

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury state II/III by AKIN criteria

  Acute kidney injury state II/III by AKIN criteria

  At 48 hours post-operative

Secondary Outcomes (4)

• Urine output during post op

  first 12 hours post op

• Urine output during post op

  daily until 3 days post op

• Concentration of Delta serum cystatin C

  24 hours post CPB

• Acute kidney injury stage

  max point within post CPB 72 hours

Other Outcomes (11)

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

  at 2 hours post CPB.

• Time to extubation (hours)

  during hospitalization, up to 8 days

• Time to chest closure (hours)

  during hospitalization, up to 3 days

Study Arms (2)

Aminophylline pre CPB & immediately post CPB

ACTIVE COMPARATOR

Drug: Aminophylline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aminophylline DRUG

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.

Aminophylline pre CPB & immediately post CPB

Placebo DRUG

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

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead

Study Sites (2)

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Aminophylline; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions

Central Study Contacts

Lauren Davis

CONTACT

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

Kerry Moore, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Cohort 1 will consist of all children undergoing open heart surgery for congenital heart defects with or without circulatory arrest, and Cohort 2 will consist of Orthotopic heart transplantation patients. All subjects will be randomized 1:1 to aminophylline or saline placebo. Cohort 1 will be randomized using block-stratification with stratification factors age (neonate vs infant) and circulatory arrest (yes vs no). Age will be categorized as neonates (0 to \<28 days) and infants (28 days to \<1 year). A total of 80 (60 in Cohort 1 and 20 in Cohort 2) participants are expected to be enrolled on this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor UTHSC

Model Details: 1 Patient randomization groups A) Group 1: Aminophylline pre CPB \& immediately post cardiopulmonary bypass (CPB) B) Group 2: No aminophylline prophylaxis

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: April 1, 2019
• Study Start: February 7, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2024
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)