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Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery (KIDPROAM)

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aminophylline

Placebo

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury (AKI), Cardiopulmonary bypass (CPB)

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Less than 18 years old, undergoing cardiac surgery with bypass
neonates must be at least 36 weeks gestational age

Exclusion Criteria:

History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy

Sites / Locations

Lucile Packard Childrens' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aminophylline

Placebo

Arm Description

Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Normal Saline Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01245595

First Posted

November 19, 2010

Last Updated

June 3, 2015

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01245595

Brief Title

Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

Acronym

KIDPROAM

Official Title

A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

Acute Kidney Injury (AKI), Cardiopulmonary bypass (CPB)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aminophylline

Arm Type

Active Comparator

Arm Description

Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal Saline Placebo

Intervention Type

Drug

Intervention Name(s)

Aminophylline

Other Intervention Name(s)

treatment

Intervention Description

5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal Saline

Primary Outcome Measure Information:

Title

Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria

Description

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

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Less than 18 years old, undergoing cardiac surgery with bypass neonates must be at least 36 weeks gestational age Exclusion Criteria: History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

david m axelrod, md

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lucile Packard Childrens' Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

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