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

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ClinicalTrials.gov Identifier: NCT01700998
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Brief 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.

Condition or disease Intervention/treatment Phase
Hypomagnesemia Drug: Magnesium Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients
Study Start Date : September 2012
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Experimental: Magnesium
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



Primary Outcome Measures :
  1. Incidence of acute renail failure [ Time Frame: During ICU stay, an expected average of 2 weeks ]

Secondary Outcome Measures :
  1. Rate of recovery from ARF [ Time Frame: During hospital stay, an expected average of 5 weeks ]
  2. ICU and hospital length of stay [ Time Frame: Hospital discharge, an expected average of 5 weeks ]
  3. ICU and hospital mortality [ Time Frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700998


Locations
Brazil
Hospital Sao Jose
Criciuma, SC, Brazil, 88801
Sponsors and Collaborators
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Investigators
Study Chair: Cristiane Ritter, MD, PhD UNESC

Responsible Party: Felipe Dal Pizzol, MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
ClinicalTrials.gov Identifier: NCT01700998     History of Changes
Other Study ID Numbers: MgICU
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Critical Illness
Renal Insufficiency
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases