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CompletedNCT01700998Updated Nov 4, 2014

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

An interventional study of Magnesium and Placebo in Hypomagnesemia, sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-04.

Sponsored by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypomagnesemia
03

In context

Lead sponsor

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of acute renail failure

    Time frame: During ICU stay, an expected average of 2 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • Hospital Sao Jose
    Criciúma, Santa Catarina 88801, Brazil
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012 and a primary completion of Oct 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2012
First posted
Oct 4, 2012
Start
Sep 2012
Primary completionActual
Oct 2014
Last update
Nov 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01700998
Lead sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Responsible party
Felipe Dal Pizzol (MD, PhD, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude) — Principal investigator
First posted
Oct 4, 2012
Start date
Sep 2012
Primary completion
Oct 2014
Last update
Nov 4, 2014

Study contacts

Cristiane Ritter, MD, PhD
study chair · UNESC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Magnesium

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