NCT05829317

Brief Summary

A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
25mo left

Started Aug 2023

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Aug 2023Jul 2028

First Submitted

Initial submission to the registry

March 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 20, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

March 15, 2023

Last Update Submit

September 17, 2025

Conditions

Critical IllnessNew Onset Atrial Fibrillation

Keywords

ProphylaxisPrevention

Outcome Measures

Primary Outcomes (2)

  • RCT Feasibility

    To assess feasibility of patient recruitment, randomization procedures, intervention and data collection and measure protocol adherence. Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 18 hours (+1hr window) of 1st ICU intervention (life sustaining therapy) delivery of all additional

    90 days

  • RCT Feasibility

    Recruitment rate of ≥ 2 patients/month/ICU

    90 days

Secondary Outcomes (5)

  • Equipoise and Feasibility

    365 days

  • Acute Care Outcomes

    28 days

  • Hospital Outcomes

    28 days

  • Adverse Events

    28 days

  • Functional Outcomes

    365 days

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses

Drug: Magnesium sulfate

0.9% NaCl

PLACEBO COMPARATOR

100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses

Drug: Placebo

Interventions

Magnesium sulfateDRUG

Intravenous Magnesium sulfate

Magnesium Sulfate
PlaceboDRUG

0.9% NaCl

0.9% NaCl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Admitted to an ICU with one or more of the following:
  • Non-invasive ventilation (including CPAP, Bipap and high flow oxygen (\>10L/min) or invasive mechanical ventilation with an expected duration \>24 hours for respiratory failure (hypercarbic or hypoxic)
  • Vasopressor or inotropic support with an expected duration of \>24 hours
  • Cardiac arrest
  • Continuous cardiac monitoring.

You may not qualify if:

  • Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for \>18 hours
  • Receiving IMV for airway protection only (for example, isolated head trauma)
  • Active atrial fibrillation at the time of enrolment
  • On oral or continuous infusion of Amiodarone
  • Unlikely to survive \>24 hours or palliative patients
  • Cardiac surgery patients
  • Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
  • Patients receiving dialysis
  • Positive pregnancy test (females \<50 years old)
  • Previously enrolled in this trial
  • Treating physician refuses enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 1Y3, Canada

NOT YET RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Stephanie Sibley, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda Hunt

CONTACT

613 549 6666miranda.hunt@kingstonhsc.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 25, 2023

Study Start

August 20, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

CA(4)