Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study (CaRDIO)

The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia

Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Study Overview

• Status: Completed
• Conditions: Cardiac Arrythmias
• Intervention / Treatment: Drug: Carbetocin

Detailed Description

Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
• American Society of Anesthesiologists (ASA) class 2
• Patients ≥ 19 years of age

Exclusion Criteria:

• Long QT syndrome
• Cardiac disease or rhythm abnormalities
• Family history of long QT syndrome or abnormal cardiac conduction
• Currently taking medication that is known to prolong the QT interval
• Women who are high risk for uterine atony as outlined in SOGC
• Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
• Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Participant receives 50 mcg of carbetocin post-delivery.	Drug: Carbetocin; 50 mcg or 100 mcg bolus of carbetocin
EXPERIMENTAL: Participant receives 100 mcg of carbetocin post-delivery.	Drug: Carbetocin; 50 mcg or 100 mcg bolus of carbetocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tp-e	Time interval between peak and end of T-wave (Tp-e)	5 minutes post-carbetocin administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia	Occurrence of Atrial or Ventricular Arrhythmias	perioperatively, typically ranging 30 minutes-1 hour
QTc at 5 Min	Bazette corrected Q-T interval	5 min post-carbetocin administration
QTc 10 Min	Bazette corrected Q-T interval (QTc)	10 minutes post-carbetocin administration
QTc 5 Min Spinal	Bazette corrected Q-T interval change after spinal anesthesia	5 min post-administration of spinal anesthesia
Tp-e 5 Min Post-spinal	Time between peak and end of T-wave,	5 minutes after administration of spinal anesthesia
Tp-e at 10 Min	Time between peak and end of T-wave	10 minutes post-carbetocin administration

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

General Publications

• Clunies-Ross N, Roston TM, Taylor J, Whyte S, Albert A, Gorges M, Chau A. The Effect of Carbetocin Dose on Transmural Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective, Randomized Clinical Trial. Anesth Analg. 2021 Feb 1;132(2):485-492. doi: 10.1213/ANE.0000000000004712.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): June 15, 2019
• Study Completion (ACTUAL): April 24, 2020

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Carbetocin; Myocardial repolarization
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Carbetocin
• Other Study ID Numbers: H18-02232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No