Magnesium Sulphate for Severe Hand, Foot and Mouth Disease in Vietnam
Hand, Foot and Mouth Disease
About this trial
This is an interventional treatment trial for Hand, Foot and Mouth Disease focused on measuring Hand, foot and mouth disease, Autonomic nervous system dysregulation, Magnesium sulphate
Eligibility Criteria
Inclusion Criteria:
- Age 6 months to 15 years
- Clinical suspicion of HFMD requiring PICU/HDU admission
- Considered severe enough to warrant invasive blood pressure monitoring by PICU/HDU staff
Development of hypertension defined as follows:
- For children aged 1 year and over, at least 3 consecutive systolic blood pressure recordings above the 95th centile for age, gender and length (USA guidelines for defining Stage 1 hypertension in children, (Appendix 2)) measured invasively over a period of 20 minutes provided the child is not distressed or crying [30, 31].
- For children aged 6 months to 1 year, systolic BP > 100 mm Hg measured invasively on at least 3 occasions over a period for 20 minutes provided the child is not distressed or crying
Plus one or more of the following criteria:
- Tachypnoea for age
- Irregular or labored breathing, but with SpO2 above 92% in air and normal ABG (pH, pCO2, pO2, HCO3 all within the normal range for the local laboratory)
- Resting heart rate > 150 bpm
- Mottled skin
- Profuse sweating
- Refractory fever
- Hyperglycemia
- Informed consent
Exclusion Criteria:
- Past history of hypertension, chronic renal, cardiac or pulmonary disease, or any neurological disorder
- Hypertensive emergency
- Already commenced milrinone or any other inotropic agents
- Respiratory distress with SpO2<92% in air or PaCO2>45 mm Hg
- AV block or any arrhythmia
- Acute renal failure
Sites / Locations
- Children's Hospital 1
- Hospital for Tropical Diseases
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Sterile water
Magnesium sulphate
Sterile water will be packaged identically to the active comparator. Each patient randomized to the placebo arm of the trial will receive a loading dose of 0.5ml/kg intravenous over 20 minutes , followed by a maintenance dose of 0.3 ml/kg/hr to 0.5 ml/kg/hr randomly adjusted by an independent doctor to mimic adjustments made in the active comparator arm for 72 hrs.
Each patient randomized to the treatment arm of the trial will receive a loading dose of 50mg/kg intravenous over 20 minutes (0.5ml/kg), followed by a maintenance dose of 30-50 mg/kg/hr (0.3 ml/kg/hr to 0.5 ml/kg/hr) for 72 hrs. The maintenance dose will be determined by increasing the loading infusion dose 0.1 ml/kg/hr (10mg/kg/hr) every 15 minutes to a maximum dose of 0.5 ml/kg/hr (50 mg/kg/hr), with the following caveats: If the systolic BP decreases to < 90th percentile for age, gender and length the dose will be reduced by 1 stage every 15 mins If the systolic BP increases to the levels detailed in the study protocol for treatment failure, action will be taken as indicated If the systolic BP decrease rapidly more than 25% over 15 minutes If the plasma Mg level > 2.5 mmol/l or < 1.8 mmol/l a 25% increase or decrease in the infusion rate will be implemented as appropriate.