Details

Autor(en) / Beteiligte

• Phan, Qui Tu
• Phung, Lam Khanh
• Truong, Khanh Huu
• Huynh, Trieu Trung
• Phạm, Giang Thanh
• Nguyen, Bich Ngọc
• Tran, Quyen Thanh
• Huynh, Vuong Ngoc Thien
• Nguyen, Tien Thi My
• Le, Thoa Phan Kim
• Le, Nhan Nguyen Thanh
• Sabanathan, Saraswathy
• van Doorn, H Rogier
• Van Le, Tan
• Nguyen, Toan Duc
• Merson, Laura
• Nguyen, Dung Thi Phuong
• Geskus, Ronald
• Nguyen, Hung Thanh
• Nguyen, Chau Van Vinh
• Wills, Bridget

Titel

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

Ist Teil von

• BMC infectious diseases, 2019-08, Vol.19 (1), p.737-12, Article 737

Ort / Verlag

England: BioMed Central Ltd

Erscheinungsjahr

2019

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Brainstem encephalitis is a serious complication of hand foot and mouth disease (HFMD) in children. Autonomic nervous system (ANS) dysregulation and hypertension may occur, sometimes progressing to cardiopulmonary failure and death. Vietnamese national guidelines recommend use of milrinone if ANS dysregulation with Stage 2 hypertension develops. We wished to investigate whether magnesium sulfate (MgSO ) improved outcomes in children with HFMD if used earlier in the evolution of the ANS dysregulation (Stage 1 hypertension). During a regional epidemic we conducted a randomized, double-blind, placebo-controlled trial of MgSO in children with HFMD, ANS dysregulation and Stage 1 hypertension, at the Hospital for Tropical Diseases in Ho Chi Minh city. Study participants received an infusion of MgSO or matched placebo for 72 h. We also reviewed data from non-trial HFMD patients in whom milrinone failed to control hypertension, some of whom received MgSO as second line therapy. The primary outcome for both analyses was a composite of disease progression within 72 h - addition of milrinone (trial participants only), need for ventilation, shock, or death. Between June 2014 and September 2016, 14 and 12 participants received MgSO or placebo respectively, before the trial was stopped due to futility. Among 45 non-trial cases with poorly controlled hypertension despite high-dose milrinone, 33 received MgSO while 12 did not. There were no statistically significant differences in the composite outcome between the MgSO and the placebo/control groups in either study (adjusted relative risk (95%CI) of [6/14 (43%) vs. 6/12 (50%)], 0.84 (0.37, 1.92), p = 0.682 in the trial and [1/33 (3%) vs. 2/12 (17%)], 0.16 (0.01, 1.79), p = 0.132 in the observational cohort). The incidence of adverse events was similar between the groups. Potentially toxic magnesium levels occurred very rarely with the infusion regime used. Although we could not demonstrate efficacy in these studies, there were no safety signals associated with use of 30-50 mg/kg/hr. MgSO in severe HFMD. Intermittent outbreaks of HFMD are likely to continue across the region, and an adequately powered trial is still needed to evaluate use of MgSO in controlling hypertension in severe HFMD, potentially involving a higher dose regimen. ClinicalTrials.gov Identifier: NCT01940250 (Registered 22 AUG 2013). Trial sponsor: University of Oxford.