Atrial Fibrillation New OnsetPhase 2/3POMPAENCT05669417
Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.
A Phase 2/3 study testing Magnesium sulfate in people with Atrial Fibrillation New Onset, run by HagaZiekenhuis at 1 site in Netherlands.
Trial summary
Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Magnesium sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2022to 6 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
- Mentally competent
Who cannot join
- History of atrial fibrillation (AF) or atrial flutter.
- Concomitant rhythm associated procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)).
- Pre-existing severe renal impairment (eGFR<30 ml/min).
- Pre-existing 3rd degree heart block without pacemaker presence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Magnesium Sulfate Versus Placebo on the Prevention of Atrial Fibrillation Post Cardiac Surgery.
Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity. Hypomagnesemia has been observed frequently immediately after cardiac surgery. Both reduction of abnormal atomicity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. The POMPAE trial will analyse the effectiveness of MgSO4 versus placebo (double blind randomized trial) in the prevention of POAF after cardiac surgery.
Read the detailed description
Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. (1) Within this population, AF is considered to be multifactorial in origin (2) but associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. (3,4) Multiple interventions have been tried before including anti-arrhythmic drugs (amiodaron, verapamil, sotalol) and rate reducing agents like beta-blockers. (5-7) Although encouraging results have been found with different regimes, adaptation in clinical practice has been hampered by toxicity (amiodarone) and therapeutic index. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity; besides, hypomagnesemia has been observed frequently immediately after cardiac surgery. (8,9) Both reduction of abnormal activity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. (10) Magnesium metabolism has identified that less then 1% of the total magnesium content is intravascular and serum levels don't always correlate with intracellular concentrations. (11) Hypomagnesaemia is associated with increased ventricular tachycardia and atrial fibrillation which is likely caused by a reduction in membrane triphosphate (ATP) activity. This results in reduced membrane stabilization due to a reduction in intracellular potassium compared to extracellular concentrations thus increasing electrical excitability. (12) Also measuring the intracellular concentration is difficult and especially in a routine fashion as loading tests followed by 24 hour urine analysis (13) and energy-dispersive X-ray analysis are not available. (14) Administration of magnesium sulphate does however correlate to higher intracellular magnesium concentration compared to placebo. (14) Several studies in different populations have shown a reduction in arrhythmias post magnesium supplementation. (15) Previous studies suggest that magnesium administration after cardiac surgery is effective in reducing the incidence of AF. (16) However, uncertainty remains regarding optimal dose/blood levels, duration and method of magnesium administration. (17) In a recent study using a protocol for administration of magnesium aiming for blood levels between 1.5 and 2.0 mmol/L an absolute reduction of POAF of 15.1% (OR 0.49, 95% CI 0.27-0.92) was demonstrated. (18) Based on this study, we designed the POMPAE trial (Peri-Operative Magnesium infusion to Prevent Atrial fibrillation Evaluated). The POMPAE trial is a double blinded randomized clinical trial to investigate the efficacy of magnesium supplementation and the reduction of POAF.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Magnesium sulfate
- Keywords
- Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Also called magnesium
Based on serum levels, bolus and or continuous administration is provided as dictated by study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Active comparator | Magnesium sulfate is the active compound and will be administered to achieve plasma serum level of magnesium between 1.5 and 2.0 mmol/L according to the study protocol. Receives: Drug: Magnesium sulfate |
| Ringers Lactate | Placebo comparator | Ringers Lactate is the comparator/placebo and will be administered according to the study protocol. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset postoperative atrial fibrillation (POAF)
New-onset POAF over a period of 5 minutes or longer
Measured: First seven postoperative days
Secondary outcomes (7)
28-day postoperative atrial fibrillation (POAF) post-surgery
The incidence of POAF in the first 28 days post surgery diagnosed with ECG
Measured: 28 days post surgery
Duration of POAF and peak heart rate recorded
The duration of POAF as recorded in the patient chart including the peak heart rate (in bpm)
Measured: 28 days post surgery
Length of hospital stay
The total length of hospital stay from day of admission until hospital discharge irrespective of outcome (diseased, home, rehab etc)
Measured: Total duration of hospital stay
Length of ICU stay
The total length of ICU stay from the moment post surgery until discharge to the ward. Possible readmissions are not part of this outcome parameter
Measured: Total length of ICU stay after surgery
Duration of mechanical ventilation
The total length of invasive mechanical ventilation from the moment post surgery until discharge to the ward. Possible readmissions are not part of this outcome parameter
Measured: Total length of mechanical ventilation during ICU stay after surgery
Duration of inotropic and/or vasopressor support
The duration of inotropic and/or vasopressor support from the start of anaesthesia until discharge to the ward. Possible readmissions are not part of this outcome parameter
Measured: Total length of inotropic/vasopressor support from induction of anaesthesia until ICU discharge
Combined outcome including 28-day post-surgery mortality, stroke, pulmonary embolism, delirium (requiring any form of anti-psychotic medication and/or infection requiring antibiotics
The incidence of the combined outcome of 28-day mortality (outcome 2), the incidence of stroke as per advise neurology department, pulmonary embolism (Ct diagnosis), delirium requiring antipsychotics and/or the use of antibiotics apart from surgical/ICU prophylaxis.
Measured: 28 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Aug 2022
- Primary completion17 Jul 2023
- Study completion6 Aug 2023
Why it stopped: Futility after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- HagaZiekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Ludikhuize, HagaZiekenhuis
- Investigators
- Jeroen Ludikhuize, MD, PhD, Principal investigator, Medical specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669417
- Sponsor's protocol ID
- T-21-118
- Acronym
- POMPAE
- Status last verified
- Aug 2024
- First submitted
- 8 Dec 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If required and request is made, this will be discussed within the study group and shared if no concerns are raised.
Publications
Meerman M, Buijser M, Neto AS, van den Berg L, van den Heuvel AM, Hoohenkerk G, van Driel V, Munsterman L, de Vroege R, Bailey M, Bellomo R, Ludikhuize J. Magnesium Sulfate to Prevent Perioperative Atrial Fibrillation in Cardiac Surgery: A Randomized Clinical Trial. Crit Care Med. 2026 Jul 1;54(7):1635-1646. doi: 10.1097/CCM.0000000000007162. Epub 2026 May 28.
PubMed 42206948Meerman M, Buijser M, van den Berg L, van den Heuvel AM, Hoohenkerk G, van Driel V, Munsterman L, de Vroege R, Bailey M, Bellomo R, Ludikhuize J. Magnesium sulphate to prevent perioperative atrial fibrillation in cardiac surgery: a randomized clinical trial : A protocol description of the PeriOperative Magnesium Infusion to Prevent Atrial fibrillation Evaluated (POMPAE) trial. Trials. 2024 Aug 15;25(1):540. doi: 10.1186/s13063-024-08368-3.
PubMed 39148128
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Magnesium Sulfate Versus Placebo on the Prevention of Atrial Fibrillation Post Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT05669417
- Acronym / sponsor ID
- POMPAE / T-21-118
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- Cardiac surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility after interim analysis
- Enrolment
- 265 participants (actual)
- Lead sponsor
- HagaZiekenhuisUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity. Hypomagnesemia has been observed frequently immediately after cardiac surgery. Both reduction of abnormal atomicity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. The POMPAE trial will analyse the effectiveness of MgSO4 versus placebo (double blind randomized trial) in the prevention of POAF after cardiac surgery.
Detailed description
Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. (1) Within this population, AF is considered to be multifactorial in origin (2) but associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. (3,4) Multiple interventions have been tried before including anti-arrhythmic drugs (amiodaron, verapamil, sotalol) and rate reducing agents like beta-blockers. (5-7) Although encouraging results have been found with different regimes, adaptation in clinical practice has been hampered by toxicity (amiodarone) and therapeutic index. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity; besides, hypomagnesemia has been observed frequently immediately after cardiac surgery. (8,9) Both reduction of abnormal activity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. (10) Magnesium metabolism has identified that less then 1% of the total magnesium content is intravascular and serum levels don't always correlate with intracellular concentrations. (11) Hypomagnesaemia is associated with increased ventricular tachycardia and atrial fibrillation which is likely caused by a reduction in membrane triphosphate (ATP) activity. This results in reduced membrane stabilization due to a reduction in intracellular potassium compared to extracellular concentrations thus increasing electrical excitability. (12) Also measuring the intracellular concentration is difficult and especially in a routine fashion as loading tests followed by 24 hour urine analysis (13) and energy-dispersive X-ray analysis are not available. (14) Administration of magnesium sulphate does however correlate to higher intracellular magnesium concentration compared to placebo. (14) Several studies in different populations have shown a reduction in arrhythmias post magnesium supplementation. (15) Previous studies suggest that magnesium administration after cardiac surgery is effective in reducing the incidence of AF. (16) However, uncertainty remains regarding optimal dose/blood levels, duration and method of magnesium administration. (17) In a recent study using a protocol for administration of magnesium aiming for blood levels between 1.5 and 2.0 mmol/L an absolute reduction of POAF of 15.1% (OR 0.49, 95% CI 0.27-0.92) was demonstrated. (18) Based on this study, we designed the POMPAE trial (Peri-Operative Magnesium infusion to Prevent Atrial fibrillation Evaluated). The POMPAE trial is a double blinded randomized clinical trial to investigate the efficacy of magnesium supplementation and the reduction of POAF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded RCT
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Active comparator | Drug: Magnesium sulfateMagnesium sulfate is the active compound and will be administered to achieve plasma serum level of magnesium between 1.5 and 2.0 mmol/L according to the study protocol. |
| Ringers Lactate | Placebo comparator | Drug: Magnesium sulfateRingers Lactate is the comparator/placebo and will be administered according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
- Mentally competent
Key exclusion criteria (4 listed)
- History of atrial fibrillation (AF) or atrial flutter.
- Concomitant rhythm associated procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)).
- Pre-existing severe renal impairment (eGFR<30 ml/min).
- Pre-existing 3rd degree heart block without pacemaker presence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateAlso: magnesiumBased on serum levels, bolus and or continuous administration is provided as dictated by study protocol. | Drug | Magnesium Sulfate, Ringers Lactate |
Primary outcome
Incidence of new-onset postoperative atrial fibrillation (POAF)
Time frame: First seven postoperative days
New-onset POAF over a period of 5 minutes or longer
7 secondary outcomes
28-day postoperative atrial fibrillation (POAF) post-surgery
Time frame: 28 days post surgery
Duration of POAF and peak heart rate recorded
Time frame: 28 days post surgery
Length of hospital stay
Time frame: Total duration of hospital stay
Length of ICU stay
Time frame: Total length of ICU stay after surgery
Duration of mechanical ventilation
Time frame: Total length of mechanical ventilation during ICU stay after surgery
Duration of inotropic and/or vasopressor support
Time frame: Total length of inotropic/vasopressor support from induction of anaesthesia until ICU discharge
Combined outcome including 28-day post-surgery mortality, stroke, pulmonary embolism, delirium (requiring any form of anti-psychotic medication and/or infection requiring antibiotics
Time frame: 28 days post surgery
Results and safety
The study was stopped early (reason given: Futility after interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 42206948Meerman M, Buijser M, Neto AS, van den Berg L, van den Heuvel AM, Hoohenkerk G, van Driel V, Munsterman L, de Vroege R, Bailey M, Bellomo R, Ludikhuize J. Magnesium Sulfate to Prevent Perioperative Atrial Fibrillation in Cardiac Surgery: A Randomized Clinical Trial. Crit Care Med. 2026 Jul 1;54(7):1635-1646. doi: 10.1097/CCM.0000000000007162. Epub 2026 May 28.
- Derived from this study: PubMed 39148128Meerman M, Buijser M, van den Berg L, van den Heuvel AM, Hoohenkerk G, van Driel V, Munsterman L, de Vroege R, Bailey M, Bellomo R, Ludikhuize J. Magnesium sulphate to prevent perioperative atrial fibrillation in cardiac surgery: a randomized clinical trial : A protocol description of the PeriOperative Magnesium Infusion to Prevent Atrial fibrillation Evaluated (POMPAE) trial. Trials. 2024 Aug 15;25(1):540. doi: 10.1186/s13063-024-08368-3.
- Individual participant dataSharing planned: Yes. If required and request is made, this will be discussed within the study group and shared if no concerns are raised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Ludikhuize, MD, PhD principal investigator
Medical specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium sulfate in people with Atrial Fibrillation New Onset, run by HagaZiekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Futility after interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new-onset postoperative atrial fibrillation (POAF) (time frame: First seven postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.