An interventional study of Magnesium and Placebo in Hypomagnesemia, sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-04.
Sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Not applicable, Interventional, and Prevention
Acute renal failure (ARF) is a serious and common complication in hospitalized patients, occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60% in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and patients with mild hypomagnesemia do not need treatment, only the correction of the underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is associated, in humans, with acute renal failure. To date, there is no study that demonstrated a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill patients. Thus, we suggest that a treatment aimed to maintain normal magnesium levels during ICU stay can decrease the incidence of ARF. We will perform a randomized clinical trial that will include all patients admitted to an ICU that, develop hypomagnesemia. It will be excluded from the study: patients younger than 18 years, participants from other studies, pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), with a diagnosis of Torsades de Pointes or symptomatic hypomagnesemia prior to randomization. Patients included in the study will be randomized to one of the following groups: placebo (saline solution 0.9%) or 50% Magnesium Sulfate. Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate of 10.4 ml / hr. Therapy will be continued for 3 days, and repeated during ICU stay to maintain magnesium levels in the normal range. Placebo group will receive exactly the same infusion only with saline administration. The therapy will be discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. The main outcome measurement will be the occurrence of ARF during ICU stay.
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude is the lead sponsor of 15 studies on the registry; none are open to participants now.
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250 ml saline 0.9% for 24 hours in an infusion rate solution of 10.4 ml / hr for 3 days repeated during ICU stay if hypomagnesemia occurs.
Drug: Placebo
48 mEq Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate solution of 10.4 ml / hr. Therapy is continued for 3 days and repeated if hypomagnesemia occurs during ICU stay
Drug: Magnesium
Incidence of acute renail failure
Time frame: During ICU stay, an expected average of 2 weeks
Rate of recovery from ARF
Time frame: During hospital stay, an expected average of 5 weeks
ICU and hospital length of stay
Time frame: Hospital discharge, an expected average of 5 weeks
ICU and hospital mortality
Time frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks
The record gives a start of Sep 2012 and a primary completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude