CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Glucagon +3 moredrug
Likely dose
Glucagon 1 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/NCT03533179
NCT03533179Phase 4Completed

A Randomized, Participant-blinded Five-arm Crossover Study With Blinded Outcome Assessment Investigating Glucagon's Cardiovascular Effects With and Without Beta-blocker-induced Cardioinhibition.

University Hospital Bispebjerg and Frederiksberg·interventional·Posted May 23, 2018·Updated Oct 17, 2019

In Brief

A Phase 4 clinical trial evaluating Glucagon, Esmolol, and 2 other interventions for Drug Overdose and Overdose of Beta-adrenergic Blocking Drug. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This trial investigates effects of a glucagon bolus injection on heart rate, blood pressure and cardiac output during beta-blocker-induced cardiodepression. Furthermore, the effects of two different doses of intravenous glucagon on hemodynamic parameters are explored.

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 23, 2018
Enrollment StartJun 1, 2018
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.1 years ago

Interventions

Glucagondrug

Glucagon 1 mg/ml solution is dissolved in 50 ml isotonic fluid and injected as bolus corresponding to 50 micrograms/kg over 1-3 minutes from time=0 on day C+E. on day D ("glucagon 2"), 50 micrograms/kg of glucagon is infused over 30 minutes from time=0 to time =30.

Esmololdrug

Esmolol hydrochloride 10 mg/ml is infused from time -15 min to time + 30 minutes as an initial bolus followed by an infusion. infusion rate is tapered if heart rate declines below 30 beats per minute (bpm) or \>25 % from baseline, systolic blood pressure decreases below 80 mmHg or the participant experiences side effects.

Physiologic saline - glucagon dummydrug

Isotonic 0.9 % sodium chloride solution is administered as matching placebo to glucagon, and injected in identical rates on corresponding days.

Physiologic saline - esmolol dummydrug

Isotonic 0.9 % sodium chloride solution is administered as matching placebo to esmolol, and injected in identical rates on corresponding days.