STUDY OF RESPONSE TO THE DOSAGE ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF AMIODARONE IV, INTRAVENOUS HCL IN PEDIATRIC PATIENTS FROM 30 DAYS TO 16 YEARS OLD WITH CRITICAL ARRITIMIES

Not Applicable

• Conditions: -I49; I49

• Registration Number: PER-030-01
• Lead Sponsor: ABORATORIOS WYETH S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-06-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Pediatric male and female patients between 30 days and 16 years of age, who suffer any incessant supraventricular and / or ventricular arrhythmia, patients suffering from TEN, if the nodal rate is> 95th percentile for age (see Appendix III) , Heart rates in children)
• Weight between> 2 kg and <75 kg
• Informed consent (and patient approval when the investigator and / or parent or legal guardian determine that it is possible) signed by the patient´s parent or legal guardian before entering the study
• Presence of peripheral route dedicated to the loading phase of Amiodarone I.V. HCI of the study (it is preferable to have a central venous line)
• Pregnancy test in urine or negative serum in female patients> 8 years of age
• Immediate availability of transcutaneous pacemaker

Exclusion Criteria

• Use of amiodarone in the previous three months
• History of optic neuritis / optic neuropathy
• Antecedents of transplant
• Confirmed hypersensitivity to amiodarone or its components (eg iodine)
• Cardiogenic shock or acute pulmonary edema
• Second or third degree AV block, unless a pacemaker is available
• Confirmation or suspicion of clinically significant hepatic impairment
• Current enrollment in other research studies, unless they involve a surgical device or technique
• Imminent death from other causes / active resuscitation from cardiac arrest
• Confirmed congenital long Q-T syndrome
• Torsades de pointes
• Pulseless electrical activity
• Known arrhythmias induced by drug, metabolically, or by electrolytes
• Establishment of hypothermic treatment for arrhythmia at <35 ° C body temperature in the 3 hours prior to admission in the study (induced hypothermia for surgery is allowed)
• Pregnancy
• Confirmation or suspected toxicity of antiarrhythmic drugs
• Patients undergoing extracorporeal membrane oxygenation treatment (EGMO)

Study & Design

• Study Type: Interventional
• Study Design: Not specified