Critical Illness Clinical Trial
— ATOMICOfficial title:
Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
NCT number | NCT05829317 |
Other study ID # | ATOMIC |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 20, 2023 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | July 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years 2. Admitted to a critical care unit with EITHER: 1. Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration >24 hours AND/OR 2. Vasopressor or ionotropic support for shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: Dopamine Dobutamine Norepinephrine Epinephrine Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent) 3. Receiving continuous cardiac monitoring. Exclusion Criteria: 1. >12 hours from ICU admission 2. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation 3. Unlikely to survive >24 hours or palliative patients 4. Cardiac surgery patients 5. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma) 6. Transfer from another ICU 7. Patients receiving dialysis 8. Positive pregnancy test 9. Previously enrolled in this trial 10. Treating physician refuses enrollment |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University | Southeastern Ontario Academic Medical Organization (SEAMO) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Adverse patch reactions (skin irritation) | 90 days | |
Other | Adverse Events | bradycardia (HR <60 bpm); severe bradycardia (HR <50 bpm); clinically significant bradycardia (bradycardia requiring inotropes, vasopressors, external pacing, temporary pacemaker, or discontinuation of the trial medication) | 90 days | |
Other | Adverse Events | hypotension (MAP< 65mmHg, or systolic blood pressure [SBP]>20mmHg below admission baseline); clinically significant hypotension (hypotension requiring vasopressors, fluid administration, or discontinuation of the trial medication) | 90 days | |
Other | Functional Outcomes | Clinical Frailty Score | 365 days | |
Other | Functional Outcomes | EuroQoL EQ-5D | 365 days | |
Other | Functional Outcomes | death after discharge | 365 days | |
Primary | RCT Feasibility | 1) Protocol adherence = 90% (We define protocol adherence as administration of first dose of study drug within 12 hours starting supported ventilation or vasoactive medications, delivery of all additional doses of study drugs for the following 4 days in patients who do not meet any stopping criteria, including patients transferred to the ward) | 90 days | |
Primary | RCT Feasibility | 2) Recruitment rate of = 6 patients/month (2 patient/month/ICU) | 90 days | |
Primary | RCT Feasibility | 3) CardioSTAT tolerance and use = 90% (defined appropriate placement, uninterrupted wear, and returned monitors) | 90 days | |
Secondary | Acute Care Outcomes | Total number of patients developing NOAF within 14 days of enrolment | 28 days | |
Secondary | Acute Care Outcomes | Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants | 28 days | |
Secondary | Acute Care Outcomes | bleeding events | 28 days | |
Secondary | Acute Care Outcomes | thromboembolic events | 28 days | |
Secondary | Acute Care Outcomes | persistent organ disfunction | 28 days | |
Secondary | Acute Care Outcomes | mortality | 28 days | |
Secondary | Hospital Outcomes | Development of renal failure requiring dialysis | 28 days | |
Secondary | Hospital Outcomes | ICU length of stay | 28 days | |
Secondary | Hospital Outcomes | hospital length of stay | 28 days |
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