CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
metoprolol +3 moredrug
Likely dose
metoprolol 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02924454
NCT02924454Phase 4Completed

An Investigation Into the Effects of Intravenous Lipid Emulsion (ILE) on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.

Mikkel Bring Christensen·interventional·Posted Oct 5, 2016·Updated Apr 12, 2017

In Brief

A Phase 4 clinical trial evaluating metoprolol, intravenous lipid emulsion, and 2 other interventions for Drug Overdose and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The aim of this study is to investigate whether intravenous lipid emulsion is effective in attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion affects the pharmacokinetic parameters of metoprolol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartSep 1, 2016
Primary CompletionMar 10, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.7 years ago

Interventions

metoprololdrug

One hundred and twenty ml, 0.5 mg metoprolol/ml (as metoprolol tartrate) is administered as an intravenous bolus injection followed by a continuous infusion. Infusion is halted if heart rate drops below 35 bpm or systolic blood pressure drops below 80 mm Hg, or the participant experiences subjective side effects. Infusion stops at T=30 minutes.

intravenous lipid emulsiondrug

Intravenous lipid emulsion 20 % is administered as an intravenous bolus infusion (1.5 ml/kg) followed by continuous infusion (infusion rate: 0.25 ml/kg/min). Lipid emulsion infusion is stopped at T = 30 minutes.

Sodium chloride 0.9% solution - lipid emulsion dummydrug

Isotonic 0.9 % sodium chloride solution is administered as an intravenous bolus infusion (1.5 ml/kg), followed by continuous infusion (infusion rate: 0.25 ml/kg/min). Infusion is stopped at T = 30 minutes.

Sodium chloride 0.9% solution - metoprolol dummydrug

Saline solution is administered as an intravenous bolus injection followed by a continuous infusion to T=30 minutes.