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Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study (CaRDIO)

Primary Purpose

Cardiac Arrythmias

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Carbetocin
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrythmias focused on measuring Carbetocin, Myocardial repolarization

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • BC Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participant receives 50 mcg of carbetocin post-delivery.

Participant receives 100 mcg of carbetocin post-delivery.

Arm Description

Participant receives 50 mcg of carbetocin post-delivery.

Participant receives 100 mcg of carbetocin post-delivery.

Outcomes

Primary Outcome Measures

Tp-e
Time interval between peak and end of T-wave (Tp-e)

Secondary Outcome Measures

Arrhythmia
Occurrence of Atrial or Ventricular Arrhythmias
QTc at 5 Min
Bazette corrected Q-T interval
QTc 10 Min
Bazette corrected Q-T interval (QTc)
QTc 5 Min Spinal
Bazette corrected Q-T interval change after spinal anesthesia
Tp-e 5 Min Post-spinal
Time between peak and end of T-wave,
Tp-e at 10 Min
Time between peak and end of T-wave

Full Information

First Posted
October 17, 2018
Last Updated
April 22, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03716076
Brief Title
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Acronym
CaRDIO
Official Title
The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrythmias
Keywords
Carbetocin, Myocardial repolarization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participant receives 50 mcg of carbetocin post-delivery.
Arm Type
Experimental
Arm Description
Participant receives 50 mcg of carbetocin post-delivery.
Arm Title
Participant receives 100 mcg of carbetocin post-delivery.
Arm Type
Experimental
Arm Description
Participant receives 100 mcg of carbetocin post-delivery.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
50 mcg or 100 mcg bolus of carbetocin
Primary Outcome Measure Information:
Title
Tp-e
Description
Time interval between peak and end of T-wave (Tp-e)
Time Frame
5 minutes post-carbetocin administration
Secondary Outcome Measure Information:
Title
Arrhythmia
Description
Occurrence of Atrial or Ventricular Arrhythmias
Time Frame
perioperatively, typically ranging 30 minutes-1 hour
Title
QTc at 5 Min
Description
Bazette corrected Q-T interval
Time Frame
5 min post-carbetocin administration
Title
QTc 10 Min
Description
Bazette corrected Q-T interval (QTc)
Time Frame
10 minutes post-carbetocin administration
Title
QTc 5 Min Spinal
Description
Bazette corrected Q-T interval change after spinal anesthesia
Time Frame
5 min post-administration of spinal anesthesia
Title
Tp-e 5 Min Post-spinal
Description
Time between peak and end of T-wave,
Time Frame
5 minutes after administration of spinal anesthesia
Title
Tp-e at 10 Min
Description
Time between peak and end of T-wave
Time Frame
10 minutes post-carbetocin administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Chau, MD MMSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32149759
Citation
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.
Results Reference
derived

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Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

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