- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700998
Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients
November 1, 2014 updated by: Felipe Dal Pizzol, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SC
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Criciuma, SC, Brazil, 88801
- Hospital Sao Jose
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of acute renail failure
Time Frame: During ICU stay, an expected average of 2 weeks
|
During ICU stay, an expected average of 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of recovery from ARF
Time Frame: During hospital stay, an expected average of 5 weeks
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During hospital stay, an expected average of 5 weeks
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ICU and hospital length of stay
Time Frame: Hospital discharge, an expected average of 5 weeks
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Hospital discharge, an expected average of 5 weeks
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ICU and hospital mortality
Time Frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks
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Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cristiane Ritter, MD, PhD, UNESC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 2, 2012
First Posted (Estimate)
October 4, 2012
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 1, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MgICU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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