1. bookVolume 22 (2022): Edition 2 (August 2022)
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A randomized controlled trial of intravenous magnesium sulphate as an adjunct to standard therapy in atrial fibrillation

Publié en ligne: 23 Aug 2022
Volume & Edition: Volume 22 (2022) - Edition 2 (August 2022)
Pages: 91 - 101
Reçu: 14 Apr 2022
Accepté: 04 Jun 2022
Détails du magazine
License
Format
Magazine
eISSN
1338-4139
Première parution
03 Jun 2011
Périodicité
3 fois par an
Langues
Anglais
Introduction

Atrial fibrillation is one of the common arrhythmia, reported in hemodynamically unstable patients. The loss of atrial contraction and the sequential atrioventricular contraction decrease of overall cardiac output results in a severe inadequate tissue perfusion. Drugs such as verapamil, diltiazem, amiodarone, and beta blockers compromise the patient’s cardiac output by their negative inotropic effect [1,2,3]. Digoxin has a slow onset of action and is significantly less effective in states of increased sympathetic tone [4,5,6]. It also results in adverse effects with chronic dosing.

As per the American College of Emergency 2015, ventricular rate control is the primary therapeutic objective in atrial fibrillation [7].

Magnesium sulphate (MgSO4) and its analgesic effect has been shown in animal models and humans. MgSO4 competes with calcium ions in synaptic junctions and prevents the release of presynaptic acetylcholine, prolonging the effects of neuromuscular blocker agents [8, 9, 10, 11]. It has been proposed as an effective and safe adjunct in the treatment of acute asthma [12]. Magnesium had an inherent physiological association because of its effects on membrane potentials and ion transport [13]. In a meta-analysis of 5 randomized trials (n=380), the patients who had received magnesium had 3 times more likely to reach a heart rate of <100 bpm compared to digoxin [14].

However, studies were scarce in India on the safety and efficacy of magnesium sulphate infusion in atrial fibrillation.

Hence, this study aimed to analyse the safety and efficacy of magnesium sulphate infusion in addition to conventional treatment modalities in patients with atrial fibrillation. The outcome of this study is to achieve a heart rate of <100bpm, and a conversion to sinus rhythm throughout the period of infusion of magnesium sulphate.

Methods

Study Design: Prospective, randomized, double-blinded, and placebo-controlled trial.

Materials: Patients of adult age >18 years presenting with atrial fibrillation to the Emer gen cy Department, Sri Ramachandra Medical College and Research Institute, Chennai, India were considered for enrolment.

The study was performed between Nov 2007 to Nov 2008.

Patients of age >18 years presenting to ED with atrial fibrillation and a ventricular response rate of >120 beats/min were included. The exclusion criteria were a requirement for cardioversion, a systolic blood pressure of <90 mm Hg, symptomatic hypotension, a history of atrioventricular node disease, patients on permanent pacemakers, an acute myocardial infarction eligible for thrombolysis.

Ethics statement

This study followed the tenets of the Helsinki declaration and the protocol was approved by the Institutional Ethical Committee. All the included patients and their relatives were informed about the procedures and their conditions. Informed consent was obtained from the patients (those that were able to provide it) or from their relatives if the patients’ physi cal condition prevented them from signing it.

Randomization and Treatment Protocol

On arrival in the emergency room, a detailed history was taken, and a clinical examination was performed to rule out any associated illness. An informed consent was obtained from the patient’s relatives.

After the enrolment the patients were randomly allocated to one of the two groups viz the MgSO4 tratment group and the placebo group.

The inclusion criteria for both groups were similar. We used random number tables for the randomization. The individual random numbers were kept in separate envelopes so that the concealment could be maintained until the patient was included in the assigned group. The treatment group received MgSO4 and the control group received 0.9% sodium chloride in a double-blind fashion. The solutions were prepared by the coordinator of the study and the ED physician in charge of the patients during the treatment was unaware of the study medication.

Treatment group: The treatment group patients were given 40 mEq (5 g, 20 mmol) of Magne sium sulphate in 100 mL of Normal saline [NS] 20 mEq (2.5 g, 10 mmol) was given intravenously diluted in 100ml NS over a 20-minute period followed by 20 mEq (2.5 g, 10 mmol) intravenously diluted in 100ml NS over the next 2 hours. The patients were monitored with half-hourly pulse rate, oxygen saturation, and blood pressure.

The administration of the Magnesium sulphate solution started in addition to the Amiodarone infusion as the standard therapy at ED. However, there were no guidelines that amiodarone was recommended, but amiodarone is acceptable. All the patients were given efficient anticoagulant prior. Dose administered as per American college of cardiology protocol, and dose given to all patient presented to ED after counselling and consent.

Placebo: 0.9% sodium chloride+ standard therapy. In placebo, the administration of 0.9% sodium chloride solution as placebo was added to the standard therapy as Amiodarone infusion at the emergency department.

Assessment of Response: Ventricular response rate control (the pulse rate of <100 beats/ min), mean changes in the heart rate, the conversion to sinus rhythm, and major (hypotension and bradycardia) or minor adverse events.

ECG was taken before and after the infusion. Blood was drawn for a magnesium level estimation before the infusion. The patients were monitored and the rhythm was analyzed at the end of the infusion. The patients were followed up during their course of stay in the hospital, their ECG was repeated, and their heart rates were monitored continuously after the 4 MgSOinfusion.

ECHO cardiograph was performed within ED and the patients were treated accordingly with a standard treatment. Transesophageal echocardiogram (TEE) was not done.

The patients discharged from the ED were instructed to continue their regular medications.

The statistical analysis was performed using Pearson’s chi-square and Fischer's Tests. The effect of MgSO4 on pulse rate measured at various points was analyzed by the analysis of variance-ANOVA (with a random intercept and slope for each subject), with contrasts to test the research hypotheses. The effect of treatment on the binary outcomes ‘‘any pulse rate of <100bpm,’’ the conversion to sinus rhythm, and any adverse effects were analyzed using the chi-square test. The statistics package SPSS ver 18.0 was used for analyses (SPSS Inc, US).

Results
Characteristics of patients

There were fifty-five subjects in the study and the control group, of which 75% of subjects were in the MgSO4 treated group and 25% were in the placebo group. Most of the subjects presented to the emergency department were complaining of palpitations, only a few had chest pain and breathlessness [Tab 1].

Most of the subjects were in the fifth to seventh decade. The mean age in MgSO4 treated group was 72.0 years, while it was 73.0 years in the placebo group. Female preponderance was observed in both groups, such as 41.46% of male, 58.53%of female was seen in the MgSO4 treated group, whereas 14% of male and 86% of female were noted in the placebo. In the patients who were administered MgSO4, 77% had a history of antiarrhythmic drug use in the past, and 23% of the Placebo had a history of antiarrhythmic drug use in the past.

Out of the total subjects who presented to the emergency department the least heart rate at the presentation was 127 bpm & maximum heart rate was 210 bpm, maximum subjects were having heart rates ranging from 150–170bpm [Tab 2][Figure 1].

Comparison of Basic characteristics between the two groups

Characteristics MgSO4 Placebo
No randomized (n) 41 14
Sex
Male (%) 41.46 % 0.71 %
Female 58.53 % 92 %
Age, yrs., Range 72.0 (50 – 70) 73.0 (51 – 71.0 )
History of Alcohol Abuse (%) 51.95 % 72 %
History of Antiarrhythmic Use 77% 33%
History of RHD (%) 19.51 % 28.57 %
History of CAD (%) 17.07 % 21.42 %
History of Hypothyroid (%) 9.75 % 21.42 %
Currently receiving Antiarrhythmic drugs (%) 1.07 % 21.42 %
Duration of Symptoms:
Within 24 hr (n) 41 14
After 24 hr (n) 1 14
ECG after 24 hrs – Rate (Mean) 84.51 112.2
Rhythm (%) NSR (65%) AF (85%)
ICU Stay (Mean) 2.25 days 4.25 days

Fig.1

Barograph plot shows achieving pulse rate <100 beats/min

Measurement of effect of MgSO4 using ECG and pulse rate

Mean S.D S.E 95% CI P value
Drugs Given
Mgso4 1.8585 0.11175 0.01745 <0.0001
Placebo 1.8929 0.09169 0.02450
ECG rate at presentation
Mgso4 84.5122 8.54729 1.33486 <0.0001
Placebo 112.2857 7.89770 2.11075
ECG Rhythm At 24hrs
Mgso4 74.5 4.58
Placebo 25.5 3.45
Heart Rate
At Presentation to ED Mean Pulse rate difference, Beats/Min (95% CI)
MgSO4 162.7561 25.12845 3.92440 154.8246-170.6876 0.015
Placebo 177.2143 16.02008 4.28155 167.9646-186.464
After 30 minutes
MgSO4 159.3902 23.75 3.70 -12.60 (-26.32 – 1.10)
Placebo 172.0000 15.92 4.25 0.071
After 60 minutes
MgSO4 147.6829 19.63 3.066 -12.60 (-24.07 – -1.12) 0.032
Placebo 160.2857 14.35 3.836
After 90 minutes
MgSO4 129.9756 14.218 2.22 -18.31 (-27.10 – -9.51) 0.001
Placebo 148.2857 13.980 3.736
After 120 minutes
MgSO4 111.2195 8.802 1.374 -23.85 (-30.53 – -12.16) 0.001
Placebo 135.07 15.304 4.09
After 150 minutes
MgSO4 96.1220 5.58 0.87 -27.94 (-33.29 – -13.60) 0.001
Placebo 24.07 14.34 3.83
Paired Test of Heart Rate after 30 Mins & 150 Mins
Mean Std dev Std Err 95% CI P
After 30 minutes 162.6 22.57 3.044 53.77-64.95 <0.0001
After 150 minutes 103.23 14.955 2.01

At the end of the 150 minutes of Mgso4 infusion 31(70%) the subjects attained heart rate less than 100bpm and 2 subjects (14%) in the Placebo infusion attained the heart rate less than 100bpm [Fig 2].

Fig. 2

Pulse Rate monitoring up to at 24 hours after MgSO4 infusion

Achieving the heart rate of <100beats/min in the MgSO4 treated group, 84.5% achieved a heart rate <100bpm, and 65% of the subjects attained normal sinus rhythm, and in the placebo group 85% were in Atrial fibrillation and only 12.28% attained a heart rate of <100 bpm at the end of 24 hours. ECG reverted to normal in 74.5% within 24 hours in the MgSO4 treated group and in 25.5 % within 24 hours in the Placebo group [Fig.3].

Fig. 3

ICU Stay during the treatment period

Seven patients in the magnesium sulphate treated group had minor side effects like flushing, headache, and nausea, P-value =0.839, Chi-square test = 0.041, Fischer’s test = 1.00 [Tab 3] [Tab 4].

Minimum adverse effects after drug administration

Frequency Percent Valid Percent Cumulative Percent P value
Valid MgSO4 5 12.2 12.2 12.2
Placebo 2 14.3 14.3 14.3
CROSS TABULATION
Drug Administration/ Adverse effects Adverse effects Total
1.00 2.00
DRUG Administration MgSO4 Count % Within DRUG Administration 512.2% 36 87.8% 41 100.0% 0.839
% Within DRUG adverse effects 71.4% 75% 74.5%
% Of total 9.1% 65.5% 74.5%
Placebo Count 2 12 14
% Within DRUG Administration 14.3 85.7% 100%
% Within DRUG adverse effects 28.6% 25.0% 25.5%
% Of total 3.6% 21.8% 25.5%
Total Count 7 48 55
% Within DRUG Administration 12.7% 87.3% 100%
% Within DRUG adverse effects 100% 100% 100%
% Of total 12.7% 87.3% 100%

Descriptive statistics of the patient characteristics

N Minimum Maximum Sum Mean std
Statistic Statistic Statistic Statistic Statistic Std error Statistic
Age 55 32 80 2981 54.2 1.62 12.05
Heart rate at presentation 55 124 212 9154 166.43 3.219 23.87
MgSO4 55 1.7 2.1 102.7 1.867 0.014 0.107
After 30 minutes 55 125 201 8943 162.6 3.044 22.57
After 60 minutes 55 120 185 8299 150.9 2.57 19.12
After 90 minutes 55 107 169 7405 134.6 2.18 16.17
After 120 minutes 55 99 151 6451 117.29 2.016 14.95
After 150 minutes 55 89 147 5678 103.23 2.016 14.95
ECG Rate 24Hr 55 72 127 5037 91.58 1.99 14.77
ICU stay 55 1.0 6.0 124 2.25 0.17 1.322
Discussion

Magnesium is an important electrolyte in cardiovascular physiology. Magnesium sulphate is capable of increasing the conduction time and refractoriness at the atrium and the atrioven tricular nodal level while suppressing atrial automaticity. It has been found to be useful for treating various atrial tachyarrhythmias15-18 but there are few if any data on its use in paroxysmal atrial fibrillation. Our study showed that magnesium sulphate used in conjunction with other agents results in 86.4% of the patients achieving a heart rate of less than 100 beats/min compared with the placebo. The current study demonstrated that magnesium sulphate increases the rate of conversion from atrial fibrillation to sinus rhythm when added to standard therapies.

Thirteen of the 41 patients in MgSO4 treated group were on antiarrthymic drugs at the time of the admission [77%], two of the fourteen patients in the Placebo group were on anti-arrthymic drugs at the time of the admission [23%]. This indicates most of the patients presented to ED were new onset atrial fibrillation patients who were not on any medication.

Out of total patients presenting to the emergency department, most of the patients were having heart rates ranging from 150-170bpm, of which the least heart rate at the presentation was 127 bpm & the maximum heart rate was 210 bpm. At the end of 150 minutes MgSO4 infusion 31 [70%] patients [of a total of 41] attained a heart rate of < 100bpm and in the Placebo infusion, two [14%] patients [of the total of 14] attained the heart rate of < 100bpm.

These patients were followed for the next 24hrs and their heart rate and rhythm were recorded, which was not done in previous studies. Analyses at 30 min, 60 min, 90 min, and 150 min revealed mean pulse rate differences of -12.60, -12.60, -23.85, and 27.94 beats/min respectively. This shows the heart rate started to decrease once the MgSO4 infusion was started and at the end of 150 min about 31 subjects attained a heart rate of <100bpm, which proves its efficacy in atrial fibrillation patients.

In the MgSO4 treated group, 35 out of 41 patients (84.5%) achieved a heart rate less than 100beats /min and 25 of 35 patients [65%] attained normal sinus rhythm. In the placebo group, 2 of 14 patients [12.28%] achieved a heart rate less than 100beats /min and no patient attained normal sinus rhythm, 87.72% were continued to be in atrial fibrillation at the end of 24 hours. This proves the effectiveness of MgSO4 in reducing heart rate and attaining rhythm control at the end of 24hrs in conjunction with antiarrhythmic drugs when compared to the placebo.

The subjects in the MgSO4 treated group had [2.25] days of ICU stay compared to the place bo group [4.25] days. Hence, MgSO4 also reduces the duration of ICU stay, thereby reducing the cost factors and burden on the patients.

Seven patients in the magnesium sulphate treated group had minor side effects like flushing, headache, and nausea, which shows it is safe and effective in rate and rhythm control when used in conjunction with other antiarrhythmic agents in atrial fibrillation with fast ventricular rate.

In our study, the Antiarrhythmic drug used was Amiodarone and MgSO4. ECG was taken after 24 hrs to detect the Rate Rhythm and ICU Stay has been studied.

Whereas a study by David Teubner, Michael John Davey used Antiarrhythmic Drug as Digoxin, Verapamil, & Beta-blocker. They measured ECG after 24 hrs., Rate Rhythm, but ICU stay has not been taken into their study.

Our study demonstrated that MgSO4 produced a statistically significant reduction in ventricular response rates at all duration intervals up to 150 minutes. We showed that magnesium sulphate used in conjunction with other agents results in 56.4% of the patients achieving a pulse rate of less than 100 beats/min compared with the placebo. In the magnesium sulphate treated group, the majority of adverse effects were minor. Only 7 patients in the magnesium sulphate treatment group had minor side effects confirming its safety.

Numerous studies conducted on to use of intravenous magnesium injection to treat acute onset atrial fibrillation.

An event is successful cardioversion to sinus rhythm or the absence of atrial fibrillation on follow-up.

Ho KM et al., 2007, used intravenous magnesium injection and observed cardioversion or prevention; 42 events in 166 cases in Mgso4, 31 events in 161 cases in the placebo group, respectively [13].Chu et al., 2009, identified events of 2/24 in Mgso4, and 6/24 in placebo groups, respectively [19].

Cook et al., 2012, identified events of 465/595 in the Mgso4 and 457/595 in the placebo groups, respectively [20]. Sultan et al., 2012, identified events of 81/84 in the Mgso4 treated and 74/86 in the placebo groups, respectively [21]. Klinger et al., 2015, identified events of 107/186 in the MgSO4 treated and 110/177 in the placebo groups, respectively [22].

Rajagopalan et al., add to the growing evidence base on this issue by performing a randomized, double-blind, placebo-controlled trial of intravenous magnesium before electric cardioversion of AF. A total of 261 patients were enrolled with normal magnesium levels at baseline (2.1±0.2 mg/dL; 0.86±0.08 mmol/L). Their key finding was that 1-hour conversion to sinus rhythm was similar in both the magnesium-treated patients and the placebo group (86.4% magnesium versus 86.0% placebo). They also found no difference in biphasic energy requirement, or the number of shocks needed in a ramping energy protocol. Rajagopalan et al., identified events of 114/132 in the MgSO4 treated, and 111/129 in the placebo groups, respectively [23].

Literature related to the management of atrial fibrillation has analysed the evidence of the pharmacologic agents [1, 2, 3]. The literature recommends that calcium-channel blockers and b-blockers were considered as the first-line agents for rate control in patients with preserved left ventricular function.

The current study also believes that physicians can use digoxin even if it is a slow onset of effect due to uncertainty of the patients’ underlying cardiac status. The current study demonstrated that an infusion of magnesium sulphate marginally improved the early ventricular response rate control and increases the rates of conversion to sinus rhythm in rapid atrial fibrillation when added to a usual conventional pharmacological treatment.

The limitations include sample size is not adequate, the majority of patients who present to the ED with atrial fibrillation are elderly, and it is often difficult to rapidly confirm the reliability of medical history in this setting.

Conclusion

Magnesium sulphate showed a statistically significant reduction of ventricular response rates at all-time intervals up to 150 minutes. In summary, 2.5 g of IV magnesium sulfate administered along with a standard therapy in patients presenting to ED with atrial fibrillation causes improvement in the heart rate and conversion to sinus rhythm. Larger double-blind studies with this design should be done to find the potential benefits of IV MgSO4 as additional treatment along with standard drugs.

Fig.1

Barograph plot shows achieving pulse rate <100 beats/min
Barograph plot shows achieving pulse rate <100 beats/min

Fig. 2

Pulse Rate monitoring up to at 24 hours after MgSO4 infusion
Pulse Rate monitoring up to at 24 hours after MgSO4 infusion

Fig. 3

ICU Stay during the treatment period
ICU Stay during the treatment period

Comparison of Basic characteristics between the two groups

Characteristics MgSO4 Placebo
No randomized (n) 41 14
Sex
Male (%) 41.46 % 0.71 %
Female 58.53 % 92 %
Age, yrs., Range 72.0 (50 – 70) 73.0 (51 – 71.0 )
History of Alcohol Abuse (%) 51.95 % 72 %
History of Antiarrhythmic Use 77% 33%
History of RHD (%) 19.51 % 28.57 %
History of CAD (%) 17.07 % 21.42 %
History of Hypothyroid (%) 9.75 % 21.42 %
Currently receiving Antiarrhythmic drugs (%) 1.07 % 21.42 %
Duration of Symptoms:
Within 24 hr (n) 41 14
After 24 hr (n) 1 14
ECG after 24 hrs – Rate (Mean) 84.51 112.2
Rhythm (%) NSR (65%) AF (85%)
ICU Stay (Mean) 2.25 days 4.25 days

Minimum adverse effects after drug administration

Frequency Percent Valid Percent Cumulative Percent P value
Valid MgSO4 5 12.2 12.2 12.2
Placebo 2 14.3 14.3 14.3
CROSS TABULATION
Drug Administration/ Adverse effects Adverse effects Total
1.00 2.00
DRUG Administration MgSO4 Count % Within DRUG Administration 512.2% 36 87.8% 41 100.0% 0.839
% Within DRUG adverse effects 71.4% 75% 74.5%
% Of total 9.1% 65.5% 74.5%
Placebo Count 2 12 14
% Within DRUG Administration 14.3 85.7% 100%
% Within DRUG adverse effects 28.6% 25.0% 25.5%
% Of total 3.6% 21.8% 25.5%
Total Count 7 48 55
% Within DRUG Administration 12.7% 87.3% 100%
% Within DRUG adverse effects 100% 100% 100%
% Of total 12.7% 87.3% 100%

Measurement of effect of MgSO4 using ECG and pulse rate

Mean S.D S.E 95% CI P value
Drugs Given
Mgso4 1.8585 0.11175 0.01745 <0.0001
Placebo 1.8929 0.09169 0.02450
ECG rate at presentation
Mgso4 84.5122 8.54729 1.33486 <0.0001
Placebo 112.2857 7.89770 2.11075
ECG Rhythm At 24hrs
Mgso4 74.5 4.58
Placebo 25.5 3.45
Heart Rate
At Presentation to ED Mean Pulse rate difference, Beats/Min (95% CI)
MgSO4 162.7561 25.12845 3.92440 154.8246-170.6876 0.015
Placebo 177.2143 16.02008 4.28155 167.9646-186.464
After 30 minutes
MgSO4 159.3902 23.75 3.70 -12.60 (-26.32 – 1.10)
Placebo 172.0000 15.92 4.25 0.071
After 60 minutes
MgSO4 147.6829 19.63 3.066 -12.60 (-24.07 – -1.12) 0.032
Placebo 160.2857 14.35 3.836
After 90 minutes
MgSO4 129.9756 14.218 2.22 -18.31 (-27.10 – -9.51) 0.001
Placebo 148.2857 13.980 3.736
After 120 minutes
MgSO4 111.2195 8.802 1.374 -23.85 (-30.53 – -12.16) 0.001
Placebo 135.07 15.304 4.09
After 150 minutes
MgSO4 96.1220 5.58 0.87 -27.94 (-33.29 – -13.60) 0.001
Placebo 24.07 14.34 3.83
Paired Test of Heart Rate after 30 Mins & 150 Mins
Mean Std dev Std Err 95% CI P
After 30 minutes 162.6 22.57 3.044 53.77-64.95 <0.0001
After 150 minutes 103.23 14.955 2.01

Descriptive statistics of the patient characteristics

N Minimum Maximum Sum Mean std
Statistic Statistic Statistic Statistic Statistic Std error Statistic
Age 55 32 80 2981 54.2 1.62 12.05
Heart rate at presentation 55 124 212 9154 166.43 3.219 23.87
MgSO4 55 1.7 2.1 102.7 1.867 0.014 0.107
After 30 minutes 55 125 201 8943 162.6 3.044 22.57
After 60 minutes 55 120 185 8299 150.9 2.57 19.12
After 90 minutes 55 107 169 7405 134.6 2.18 16.17
After 120 minutes 55 99 151 6451 117.29 2.016 14.95
After 150 minutes 55 89 147 5678 103.23 2.016 14.95
ECG Rate 24Hr 55 72 127 5037 91.58 1.99 14.77
ICU stay 55 1.0 6.0 124 2.25 0.17 1.322

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