<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01700998</url>
  </required_header>
  <id_info>
    <org_study_id>MgICU</org_study_id>
    <nct_id>NCT01700998</nct_id>
  </id_info>
  <brief_title>Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients</brief_title>
  <official_title>Randomized Trial of Magnesium Replacement Therapy to Prevent Acute Renal Failure in Hypomagnesemic Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute renal failure (ARF) is a serious and common complication in hospitalized patients,&#xD;
      occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common&#xD;
      disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60%&#xD;
      in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and&#xD;
      patients with mild hypomagnesemia do not need treatment, only the correction of the&#xD;
      underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is&#xD;
      associated, in humans, with acute renal failure. To date, there is no study that demonstrated&#xD;
      a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill&#xD;
      patients. Thus, we suggest that a treatment aimed to maintain normal magnesium levels during&#xD;
      ICU stay can decrease the incidence of ARF. We will perform a randomized clinical trial that&#xD;
      will include all patients admitted to an ICU that, develop hypomagnesemia. It will be&#xD;
      excluded from the study: patients younger than 18 years, participants from other studies,&#xD;
      pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis,&#xD;
      patients who used intravenous contrast for radiological studies, patients weighing less than&#xD;
      40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium&#xD;
      less than or equal to 1.1 mg / dl), with a diagnosis of Torsades de Pointes or symptomatic&#xD;
      hypomagnesemia prior to randomization. Patients included in the study will be randomized to&#xD;
      one of the following groups: placebo (saline solution 0.9%) or 50% Magnesium Sulfate.&#xD;
      Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for&#xD;
      24 hours in an infusion rate of 10.4 ml / hr. Therapy will be continued for 3 days, and&#xD;
      repeated during ICU stay to maintain magnesium levels in the normal range. Placebo group will&#xD;
      receive exactly the same infusion only with saline administration. The therapy will be&#xD;
      discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. The main&#xD;
      outcome measurement will be the occurrence of ARF during ICU stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute renail failure</measure>
    <time_frame>During ICU stay, an expected average of 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of recovery from ARF</measure>
    <time_frame>During hospital stay, an expected average of 5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital length of stay</measure>
    <time_frame>Hospital discharge, an expected average of 5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital mortality</measure>
    <time_frame>Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Hypomagnesemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium</intervention_name>
    <arm_group_label>Magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients, clinical or surgical, who signed (or their relatives) the informed&#xD;
             consent form, which presented hypomagnesemia (with serum magnesium between 1.2 and 1.8&#xD;
             mg / dL), with no symptoms of hypomagnesemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years, participants from other studies, pregnant women,&#xD;
             patients with admission plasma creatinine greater than or equal to 3.5 mg / dl or on&#xD;
             dialysis, patients who used intravenous contrast for radiological studies, patients&#xD;
             weighing less than 40kg, patients suffering from advanced cancer, patients with severe&#xD;
             hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), patients with a&#xD;
             diagnosis of Torsades de Pointes or patients with symptomatic hypomagnesemia prior to&#xD;
             randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristiane Ritter, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UNESC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Sao Jose</name>
      <address>
        <city>Criciuma</city>
        <state>SC</state>
        <zip>88801</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>November 1, 2014</last_update_submitted>
  <last_update_submitted_qc>November 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</investigator_affiliation>
    <investigator_full_name>Felipe Dal Pizzol</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01700998
org study id: MgICU
nct id: NCT01700998
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of acute renail failure
time frame: During ICU stay, an expected average of 2 weeks
measure: Rate of recovery from ARF
time frame: During hospital stay, an expected average of 5 weeks
measure: ICU and hospital length of stay
time frame: Hospital discharge, an expected average of 5 weeks
measure: ICU and hospital mortality
time frame: Hospital discharge, an expected average of 2 (ICU) and 5 (hospital) weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: Magnesium
arm group type: Experimental
description: 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
intervention type: Drug
intervention name: Magnesium
arm group label: Magnesium
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristiane Ritter, MD, PhD
role: Study Chair
affiliation: UNESC
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
investigator full name: Felipe Dal Pizzol
investigator title: MD, PhD
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury