Assessing the efficacy and safety of magnesium sulfate for management of autonomic nervous system dysregulation in Vietnamese children with severe hand foot and mouth disease

Table 3 Effect of MgSO₄ on selected hemodynamic parameters in the clinical trial and the observational cohort

	Placebo / Control^a	MgSO₄	Mean difference (95% CI)	p-value
Clinical Trial (for 72 h from study drug initiation)	(N = 12)	(N = 14)
AUC of HR (beats/min x hr)
Median (range)	9728 (8820, 10,983)	9021 (8156, 11,008)
Mean (sd)	9816 (744)	9296 (931)	− 581 (− 1264, 102)	0.095
Log-10 AUC of SBP above stage 1 HTN (log10(mmHg x hr))
Median (range)	2.52 (1.80, 3.22)	2.40 (1.48, 3.09)
Mean (sd)	2.46 (0.39)	2.36 (0.47)	−0.07 (− 0.40, 0.27)	0.701
Log-10 AUC of MAP above stage 1 HTN (log10(mmHg x hr))
Median (range)	2.16 (1.00, 3.04)	2.13 (0.00, 2.69)
Mean (sd)	2.09 (0.63)	2.03 (0.68)	0.05 (−0.45, 0.55)	0.850
Observational cohort (for 24 h from study drug initiation)	(N = 12)	(N = 33)
Log-10 AUC of SBP above stage 1 HTN (mmHg x hr)^b
Median (range)	2.47 (1.82, 2.87)	2.50 (1.54, 2.83)
Mean (sd)	2.44 (0.31)	2.42 (0.33)	−0.05 (−0.26, 0.15)	0.604
Log-10 AUC of MAP above stage 1 HTN (mmHg x hr)^b
Median (range)	1.54 (0.00, 2.74)	1.62 (0.00, 2.56)
Mean (sd)	1.62 (0.72)	1.54 (0.57)	−0.17 (−0.54, 0.19)	0.354

Note: In the clinical trial the study drug was commenced at Stage 1 hypertension without milrinone, while in the observational cohort MgSO₄ was commenced at Stage 2 hypertension when the patients were already on high dose milrinone
Comparisons for AUCs of HR, SBP and MAP were based on linear regression with adjustment for their corresponding values at baseline
HR Heart rate, SBP Systolic blood pressure, MAP Mean arterial pressure, AUC Area under the curve, HTN Hypertension, sd standard deviation
^aPlacebo Group in the clinical trial and Control Group in the observational cohort
^bFor the control group, results are based on multiple imputation of the time that MgSO₄ would have commenced. The imputation model is a logistic regression model based on: a) the difference between the current SBP and the age-dependent cut-off for Stage 2 hypertension; b) the difference between the current SBP and the previous SBP value; and c) the current dose of milrinone. The descriptions were averaged across imputation datasets while the comparisons were based on Rubin’s rule (a modified rule to take into account difference in size between imputed datasets gave similar results). Detailed information describing this methodology can be found in the Additional file 1, Additional file 3: Table S2, Additional file 4: Table S3 and Additional file 5: Table S4

ISSN: 1471-2334