Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude