<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/NCT04412850</url>
  </required_header>
  <id_info>
    <org_study_id>huda01</org_study_id>
    <nct_id>NCT04412850</nct_id>
  </id_info>
  <brief_title>Intravenous Magnesium Sulphate in Acute Ischemic Stroke</brief_title>
  <official_title>Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dow University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow University of Health Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnesium has a neuroprotective role so the investigators aim to evaluate the role of&#xD;
      intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH&#xD;
      Stroke Scale (NIHSS) in patients with acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Stroke</condition>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline in equal volume as the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment.&#xD;
All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form.&#xD;
Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with a confirmed diagnosis of ischemic stroke on neurological examination and&#xD;
             CT scan findings aged between 45 -95 years of age of either gender.&#xD;
&#xD;
          -  Adults presenting within a stroke onset of 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial&#xD;
             bleed or space occupying lesion)&#xD;
&#xD;
               -  Subjects with systolic blood pressure less than 90mmHg&#xD;
&#xD;
               -  Presence of Bundle Branch block or atrioventricular block.&#xD;
&#xD;
               -  Serum Creatinine &gt; 3mg/dl&#xD;
&#xD;
               -  Respiratory failure (O2 saturation &lt;90% or Respiratory Rate &gt;24 or &lt;12)&#xD;
&#xD;
               -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Huda Naim, MBBS</last_name>
    <phone>03333656270</phone>
    <email>huda_naim@live.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Huda Naim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04412850
org study id: huda01
nct id: NCT04412850
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Magnesium has a neuroprotective role so the investigators aim to evaluate the role of
      intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH
      Stroke Scale (NIHSS) in patients with acute ischemic stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.
time frame: 7 days
measure: adverse effects
time frame: 7 days
arm group label: Control group
arm group type: Experimental
description: Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.
arm group label: placebo group
arm group type: Placebo Comparator
description: Normal Saline in equal volume as the control group.
intervention type: Drug
intervention name: Magnesium Sulfate
description: Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment.
All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form.
Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge.
arm group label: Control group
arm group label: placebo group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 95 Years
healthy volunteers: No
last name: Huda Naim, MBBS
phone: 03333656270
email: huda_naim@live.com
responsible party type: Principal Investigator
investigator affiliation: Dow University of Health Sciences
investigator full name: Huda Naim
investigator title: Principal Investigator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Magnesium Sulfate
sharing ipd: No