Rapid Versus Prolonged Inpatient Up-Titration of Captopril
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease
Intervention: Captopril (Drug); Captopril (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Paul Kantor, MD, Principal Investigator, Affiliation: The Hospital for Sick Children
Summary
The primary objective of this study is to establish a safe and effective method of
up-titration of captopril for hospital inpatients.
Clinical Details
Official title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The number of patients reaching a target dose of 1mg/kg/dose (given three times a day).
Detailed description:
Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed
pediatric cardiac medication and overall their safety in children is widely accepted.
Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0. 1
mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges
are quoted for maintenance doses and no guidance is given as to the best method of
up-titration, The physician is left uncertain of the optimal dose and how best to achieve
it.
The ultimate goal of this study is to be in a position to provide physicians caring for
children with heart disease information about how to safely up-titrate this widely used
medication, and by doing so to improve dosing in the wider pediatric population.
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pediatric cardiology in-patients at The Hospital for Sick Children
- Primary physician has decided to commence ACEi (the division has agreed that our
institutional choice will be to start patients on captopril and up-titrate to optimal
dose before converting to other ACEi)
- Patients who have been initiated on captopril within the prior 24 hours, but have not
yet started up-titration, will be eligible to be randomized
Exclusion Criteria:
- Known sensitivity to ACEi
- Infants on the neonatal intensive care unit
- Treatment with any ACEi for more than 24 hours within the preceding 6 months
- Age > 18 years
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario, Canada; Recruiting Paul Kantor, MD, Phone: (416)813-7239, Email: paul.kantor@sickkids.ca Paul Kantor, MD, Principal Investigator Lucy Roche, MD, Sub-Investigator Katherine Timberlake, MD, Sub-Investigator Brian McCrindle, MD, Sub-Investigator Mervin Balasingam, Sub-Investigator
Additional Information
Starting date: August 2008
Last updated: August 26, 2008
|