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临床试验/NCT03088852
NCT03088852招募中4 期

Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

Frieda Wolf1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2017年5月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
330
试验地点
1
主要终点
compare mortality

研究概览

简要总结

Hypomagnesemia is a common entity in the inpatient and outpatient setting. in previous retrospective study hypomagnesemic patients have higher mortality and longer hospitalization. whether hypomagnesemia is merely a marker of poor prognosis, or whether replacing it can improve outcomes is unclear. The current standard of care is to discharge these patients without workup or further treatment, even if patients had received intravenous therapy while hospitalized. The investigator wish to examine prospectively whether giving replacement therapy affects mortality, length of hospital stay and overall well-being. In order to replete intracellular levels and replete magnesium stores, magnesium should be given for several months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient admitted over the age of 18, has hypomagnesemia (magnesium level ≤1.9 mg/dL) and is able to give consent.

排除标准

  • A patient unable to give consent.
  • A patient admitted for an elective procedure.
  • A patient in critical condition or dying.
  • Patients with advanced kidney disease with eGFR<15ml/min or on dialysis.
  • Patients with severe diarrhea, precluding use of magnesium citrate.
  • Patients already receiving magnesium supplements.
  • Patients with severe malnutrition or life-threatening hypomagnesemia (serum level <1mg/dL), requiring intravenous and oral replacement of magnesium.

研究组 & 干预措施

Experimental group

Active Comparator

After initial intravenous treatment, participants (those with magnesium level ≥1 mg/dL) will be randomized, and oral magnesium therapy ( or no treatment) will be started. The experimental group will receive 400mg magnesium daily in two divided doses. Patients in the experimental group will be discharged with one month's supply of magnesium and continued for at least three months.

干预措施: Magnesium Citrate 100 MG (Drug)

结局指标

主要结局

compare mortality

时间窗: one year

To compare mortality between the population receiving magnesium and the population receiving standard care: ie no replacement.

次要结局

  • Hospitalization(one year)

研究者

发起方
Frieda Wolf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Frieda Wolf

Senior Physician in Internal Medicine C, Haemek Medical Center, Israel

HaEmek Medical Center, Israel

研究点 (1)

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