xml: <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/NCT05973747</url>
    </required_header>
    <id_info>
      <org_study_id>70603</org_study_id>
      <nct_id>NCT05973747</nct_id>
    </id_info>
    <brief_title>Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients</brief_title>
    <official_title>Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Calcium is a life saving medicine in the care of parturients. It has many important uses&#xD;
        including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of&#xD;
        hypocalcemia during blood transfusion (of citrate containing blood products), treatment of&#xD;
        hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord&#xD;
        clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved&#xD;
        forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the&#xD;
        last decade there have been times with drug shortages of either calcium chloride or calcium&#xD;
        gluconate. So there have been and likely will continue to be times when one formulation or&#xD;
        the other may not be adequately available. Despite the importance of calcium and the&#xD;
        frequency in which it is used in parturients, there are no published studies in parturients&#xD;
        to determine dose equivalence between calcium gluconate and calcium chloride. In this study&#xD;
        the investigators will determine the population pharmacokinetics of calcium gluconate and&#xD;
        calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This&#xD;
        will help clinicians select appropriate doses of calcium and provide resilience to the drug&#xD;
        supply chain in our era of frequent drug shortages.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum ionized calcium concentration</measure>
      <time_frame>Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion</time_frame>
      <description>Ionized calcium will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The ionized blood calcium levels will be immediately analyzed using an Abbott iStat machine.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum pH</measure>
      <time_frame>Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion</time_frame>
      <description>Serum pH will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These blood draws will be the same blood draws used to measure serum ionized calcium concentration, no additional blood draws will be necessary. These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The serum pH levels will be immediately analyzed using an Abbott iStat machine.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Postpartum Hemorrhage</condition>
    <condition>Pregnancy Related</condition>
    <condition>Hypocalcemia</condition>
    <condition>Parturition Complication</condition>
    <arm_group>
      <arm_group_label>Calcium Gluconate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 grams of calcium gluconate, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Calcium Chloride</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Calcium Gluconate</intervention_name>
      <description>2 grams of calcium gluconate, infused intravenously over 10 minutes upon umbilical cord clamping</description>
      <arm_group_label>Calcium Gluconate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Calcium chloride</intervention_name>
      <description>0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping</description>
      <arm_group_label>Calcium Chloride</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Pregnant female subjects delivering at the study institution via scheduled cesarean&#xD;
          delivery at term (&gt;=37 weeks gestation)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. severe range blood pressure (BP &gt;160/&gt;110) within the 48 hours prior to delivery&#xD;
  &#xD;
            2. patient age &lt;18 years or &gt;45 years&#xD;
  &#xD;
            3. renal dysfunction with serum Cr &gt; 1.0 mg/dL&#xD;
  &#xD;
            4. known history of congenital or acquired cardiac disease or history of arrhythmia&#xD;
  &#xD;
            5. patient taking digoxin&#xD;
  &#xD;
            6. patient currently taking a calcium channel blocker&#xD;
  &#xD;
            7. Weight &lt;55kg or &gt;100kg, or&#xD;
  &#xD;
            8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery&#xD;
  &#xD;
            9. administration of intraoperative doses of calcium by the anesthesiology team for&#xD;
               clinical indications&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Parturients all biologically female at birth by necessity</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessica Ansari, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica Ansari, MD, MS</last_name>
      <phone>760-845-0328</phone>
      <email>jansari@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel Conti, MD</last_name>
      <phone>805-709-5096</phone>
      <email>dconti@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lucile Packard Children's Hospital</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Jessica Ansari, MD</investigator_full_name>
      <investigator_title>Clinical Assistant Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postpartum Hemorrhage</mesh_term>
      <mesh_term>Hypocalcemia</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Calcium, Dietary</mesh_term>
      <mesh_term>Calcium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973747
  org study id: 70603
  nct id: NCT05973747
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Calcium is a life saving medicine in the care of parturients. It has many important uses
        including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of
        hypocalcemia during blood transfusion (of citrate containing blood products), treatment of
        hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord
        clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved
        forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the
        last decade there have been times with drug shortages of either calcium chloride or calcium
        gluconate. So there have been and likely will continue to be times when one formulation or
        the other may not be adequately available. Despite the importance of calcium and the
        frequency in which it is used in parturients, there are no published studies in parturients
        to determine dose equivalence between calcium gluconate and calcium chloride. In this study
        the investigators will determine the population pharmacokinetics of calcium gluconate and
        calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This
        will help clinicians select appropriate doses of calcium and provide resilience to the drug
        supply chain in our era of frequent drug shortages.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Serum ionized calcium concentration
  time frame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
  description: Ionized calcium will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The ionized blood calcium levels will be immediately analyzed using an Abbott iStat machine.
  measure: Serum pH
  time frame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
  description: Serum pH will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These blood draws will be the same blood draws used to measure serum ionized calcium concentration, no additional blood draws will be necessary. These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The serum pH levels will be immediately analyzed using an Abbott iStat machine.
  arm group label: Calcium Gluconate
  arm group type: Experimental
  description: 2 grams of calcium gluconate, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping
  arm group label: Calcium Chloride
  arm group type: Active Comparator
  description: 0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping
  intervention type: Drug
  intervention name: Calcium Gluconate
  description: 2 grams of calcium gluconate, infused intravenously over 10 minutes upon umbilical cord clamping
  arm group label: Calcium Gluconate
  intervention type: Drug
  intervention name: Calcium chloride
  description: 0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping
  arm group label: Calcium Chloride
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Parturients all biologically female at birth by necessity
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jessica Ansari, MD, MS
  role: Principal Investigator
  affiliation: Stanford University
  last name: Jessica Ansari, MD, MS
  phone: 760-845-0328
  email: jansari@stanford.edu
  last name: Daniel Conti, MD
  phone: 805-709-5096
  email: dconti@stanford.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Jessica Ansari, MD
  investigator title: Clinical Assistant Professor of Anesthesiology
  mesh term: Postpartum Hemorrhage
  mesh term: Hypocalcemia
  mesh term: Hemorrhage
  mesh term: Calcium, Dietary
  mesh term: Calcium
  sharing ipd: No