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Trial · Interventional

CompletedPhase 4Registry data

Glucagon's Cardiovascular Effects With and Without Beta-blocker-induced Cardioinhibition

Short name GLUCAGON

NCTNCT03533179 (opens ClinicalTrials.gov in a new tab)Other idGlucagon+Beta-blocker
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
10 participants (actual)
Sponsor
University Hospital Bispebjerg and Frederiksberg · Other
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
1 Jun 2018
Primary completion
1 Oct 2019
Completion
1 Oct 2019
First posted
23 May 2018
Last update posted
17 Oct 2019
Conditions
Drug Overdose · Overdose of Beta-adrenergic Blocking Drug

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 4

    GLUCAGON

    NCT03533179

    1 Jun 2018 to 1 Oct 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GlucagonDrug
  • EsmololDrug
  • Physiologic saline - glucagon dummyDrug
  • Physiologic saline - esmolol dummyDrug

Arms5

  • Experimental

    Esmolol-placebo+glucagon 1 placebo (A)

    Physiologic saline - esmolol dummy (10 mg esmolol/ml) is administered as a loading dose at baseline (time= -15 minutes) (corresponding to 0.125 ml/kg/min of saline). Continuous infusion (0.05-0.075 ml/kg/min) of saline is then administered until T=30 minutes. \+ Physiologic saline - glucagon dummy bolus 50 ml at time=0.

  • Experimental

    Esmolol+glucagon 1 placebo (B)

    Esmolol intravenous solution (10 mg/ml esmolol hydrochloride) is administered as a loading dose (1.25 mg/kg/min esmolol) at baseline (time= -15 minutes). Continuous infusion (500-750 micrograms/kg/min) of esmolol/placebo is then administered until T=30 minutes. \+ Physiologic saline - glucagon dummy bolus (50 ml) at time=0.

  • Experimental

    Esmolol+glucagon 1 (C)

    Esmolol intravenous solution (10 mg/ml esmolol hydrochloride) is administered as a loading dose (1.25 mg/kg/min esmolol) at baseline (time= -15 minutes). Continuous infusion (500-750 micrograms/kg/min) of esmolol/placebo is then administered until T=30 minutes. +Glukagon 1 (50 μg/kg bolus - over 1-3 min from time=0 min in 50 ml isotonic fluid)

  • Experimental

    Esmolol-placebo+glucagon 2 (D)

    Physiologic saline - esmolol dummy (10 mg esmolol/ml) is administered as a loading dose at baseline (time= -15 minutes) (corresponding to 0.125 ml/kg/min of saline). Continuous infusion (0.05-0.075 ml/kg/min) of saline is then administered until T=30 minutes. +Glukagon 2 (50 μg/kg bolus - over 30 min in 50 ml isotonic fluid from time=0 min)

  • Experimental

    Esmolol-placebo+glucagon 1 (E)

    Physiologic saline - esmolol dummy (10 mg esmolol/ml) is administered as a loading dose at baseline (time= -15 minutes) (corresponding to 0.125 ml/kg/min of saline). Continuous infusion (0.05-0.075 ml/kg/min) of saline is then administered until T=30 minutes. \+ Glukagon 1 (50 μg/kg bolus - over 1-3 min from time=0 min in 50 ml isotonic fluid)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Heart rates on the esmolol+glucagon-day compared to the esmolol+placebo-day (2 minute average)

    Time frame · Glucagon bolus + 5±1 minute

    Registry description

    Arterial catheter connected to a pressure transducer records heart rate (beats per minute).

Secondary outcomes(6)

  1. Change in heart rate from baseline compared between study days.

    Time frame · -20, -10, 0, glucagon+3, +5, +10, +15, +20, +30, +40, +50, +60 minutes

    Registry description

    Arterial catheter connected to a pressure transducer records heart rate (beats per minute).

  2. Change in stroke volume (ml) from baseline compared between study days.

    Time frame · -20, -10, 0, glucagon+3, +5, +10, +15, +20, +30, +40, +50, +60 minutes

    Registry description

    Stroke volume (ml) derived from arterial pulse contour analysis.

  3. Change in systolic, diastolic and mean arterial pressure (mmHg) from baseline compared between study days.

    Time frame · -20, -10, 0, glucagon+3, +5, +10, +15, +20, +30, +40, +50, +60 minutes

    Registry description

    Arterial catheter connected to a pressure transducer records blood pressure in mm Hg.

  4. Glucagon pharmacokinetics

    Time frame · Baseline and glucagon +2, +4, +6, +10, +15, +20, +30, +40, +50, +60 minutes

    Registry description

    Blood samples drawn for measurements of plasma glucagon

  5. Effects of glucagon on blood glucose compared to placebo

    Time frame · Baseline and glucagon +2, +4, +6, +10, +15, +20, +30, +40, +50, +60 minutes

    Registry description

    Full blood glucose measured with a blood glucose meter

  6. Adverse effects of glucagon

    Time frame · Baseline and glucagon +6,+10, +30, +60 minutes

    Registry description

    Nausea rated by a 4-point, verbal description scale (VDS) (no nausea=0, mild=1, moderate=2, severe=3).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Review · 2016

Calcium channel antagonist and beta-blocker overdose: antidotes and adjunct therapies.

Graudins et al. 2016British journal of clinical pharmacologycited by 92

PMID 26344579PMC4767195DOI 10.1111/bcp.12763PUB-26344579

Rights unknown
Source link

Indexing hint: Systematic review · 2014

Treatment for calcium channel blocker poisoning: a systematic review.

St-Onge et al. 2014Clinical toxicology (Philadelphia, Pa.)cited by 101

PMID 25283255PMC4245158DOI 10.3109/15563650.2014.965827PUB-25283255

Free to read · publisher termsCC BY-NC-ND
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPetersen KM, Bogevig S, Riis T, Andersson NW, Dalhoff KP, Holst JJ, Knop FK, Faber J, Petersen TS, Christensen MB. High-Dose Glucagon Has Hemodynamic Effects Regardless of Cardiac Beta-Adrenoceptor Blockade: A Randomized Clinical Trial. J Am Heart Assoc. 2020 Nov 3;9(21):e016828. doi: 10.1161/JAHA.120.016828. Epub 2020 Oct 26. PMID 33103603

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male determined by investigator, based upon physical examination, medical history, ECG, vital signs and laboratory results * Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 and body weight between 50 and 100 kg, inclusive, at screening visit. Exclusion Criteria: * Abnormal blood levels of sodium, potassium, creatinine, alanine transaminase (ALT), alkaline phosphatase, albumin, bilirubin, hemoglobin, HbA1c, cholesterol fractions. * Bradycardia (\<45 beats per minute) * Hypotension (systolic blood pressure \< 100 mmHg) * Second or third degree atrioventricular conduction delay * Sick sinus syndrome * Any heart disease or hypertension * Pheochromocytoma * Allergy to any active or inactive ingredient contained in investigatory medicines or tools. * Raynaud's syndrome * Prinzmetal's angina * Diabetes * Pulmonary disease * Pheochromocytoma * Any contraindication against investigatory medicines or tools.

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