Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients
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Purpose
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 | Intervention |
|---|---|
|
Hypomagnesemia |
Drug: Magnesium Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients |
- Incidence of acute renail failure [ Time Frame: During ICU stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
- Rate of recovery from ARF [ Time Frame: During hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
- ICU and hospital length of stay [ Time Frame: Hospital discharge, an expected average of 5 weeks ] [ Designated as safety issue: No ]
- ICU and hospital mortality [ Time Frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Felipe Dal-Pizzol, MD, PhD | +55 48 34312539 | piz@unesc.net |
| Brazil | |
| Hospital Sao Jose | Recruiting |
| Criciuma, SC, Brazil, 88801 | |
| Contact: Emilio L Streck, PhD +55 48 34312578 est@unesc.net | |
| Principal Investigator: Felipe Dal-Pizzol, MD, PhD | |
| Study Chair: | Cristiane Ritter, MD, PhD | UNESC |
More Information
No publications provided
| 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 |
| Study First Received: | October 1, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Additional relevant MeSH terms:
|
Critical Illness Acute Kidney Injury Renal Insufficiency Disease Attributes |
Pathologic Processes Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013