Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients

Hypomagnesemia Clinical Trial

Official title:

Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700998
• Other study ID #: MgICU
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: November 1, 2014
• Start date: September 2012

Study information

• Verified date: November 2014
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients, clinical or surgical, who signed (or their relatives) the informed consent form, which presented hypomagnesemia (with serum magnesium between 1.2 and 1.8 mg / dL), with no symptoms of hypomagnesemia.

Exclusion Criteria:

• Patients younger than 18 years, participants from other studies, pregnant women, patients with admission plasma 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, patients suffering from advanced cancer, patients with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), patients with a diagnosis of Torsades de Pointes or patients with symptomatic hypomagnesemia prior to randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Hypomagnesemia
• Renal Insufficiency

Intervention

Drug:
• Magnesium

• Placebo

Locations

Country	Name	City	State
Brazil	Hospital Sao Jose	Criciuma	SC

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute renail failure		During ICU stay, an expected average of 2 weeks	No
Secondary	Rate of recovery from ARF		During hospital stay, an expected average of 5 weeks	No
Secondary	ICU and hospital length of stay		Hospital discharge, an expected average of 5 weeks	No
Secondary	ICU and hospital mortality		Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks	No