<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/NCT03824743</url>
  </required_header>
  <id_info>
    <org_study_id>CCEI-9813-2018</org_study_id>
    <nct_id>NCT03824743</nct_id>
  </id_info>
  <brief_title>Balanced Crystalloids in Postpartum Hemorrhage</brief_title>
  <official_title>Impact of Balanced Crystalloids in Obstetric Hemorrhage: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Santa Fe de Bogota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación Santa Fe de Bogota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction:&#xD;
&#xD;
      Obstetric hemorrhage is the most feared complication that can occur during childbirth and&#xD;
      continues to be the leading cause of death in pregnant women worldwide, about 7 women die&#xD;
      every hour in the world. This is defined as an accumulated loss of blood of more than 1000 mL&#xD;
      with signs and symptoms of hypovolemia within 24 hours of the birth process. The main&#xD;
      objective of resuscitation in these patients is precisely to reduce the deleterious effects&#xD;
      that are generated from the depletion of volume and the altered capacity of oxygen transport.&#xD;
      The current debate focuses on the safety and efficacy of each particular liquid during&#xD;
      resuscitation and on improving long-term patient outcomes. At present, there is no conclusive&#xD;
      evidence on the impact at the level of acid-base status, hydroelectrolytic balance and&#xD;
      potential kidney injury with respect to the use of balanced solutions such as Plasma-Lyte or&#xD;
      Ringer's Lactate.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To determine the differences in the volume of liquids and blood products required with the&#xD;
      use of balanced crystalloids (Ringer's Lactate or Plasma-Lyte) in patients with obstetric&#xD;
      hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá during 2018 - 2019.&#xD;
&#xD;
      Design, Materials, and methods:&#xD;
&#xD;
      Historical cohort analytical study. All patients over 18 years of age who present an&#xD;
      obstetric hemorrhage defined as bleeding&gt; 1000 mL or less associated with signs or symptoms&#xD;
      of hemodynamic instability will be included. The most important exclusion criterion is the&#xD;
      presence of active infection at the time of the event. Patients will be divided into two&#xD;
      groups, those who underwent hydroelectrolytic resuscitation with Plasma-Lyte and Ringer&#xD;
      Lactate.&#xD;
&#xD;
      Results and conclusions With this study, we intend to describe the differences in the base&#xD;
      acid status measured by arterial gases in patients with obstetric hemorrhage. The aim is to&#xD;
      find a relationship between the different groups with clinical outcomes, such as days of ICU&#xD;
      stay and hospitalization, blood transfusion requirement, electrolyte disorders, acute kidney&#xD;
      injury and survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem Statement Maternal mortality is a tragic event with great social, economic and legal&#xD;
      impact. The incidence rate varies depending on the source, however, it covers 400 cases per&#xD;
      100,000 live births per year. The first cause of death in these patients is obstetric&#xD;
      hemorrhage, which generates 150,000 deaths per year in the world. Not being outside of this&#xD;
      situation, Bogotá presents a high number of women who present this complication, being the&#xD;
      cause of death in 29% of cases in the years 2012 and 2013. Once this problem is identified,&#xD;
      multiple strategies have sought to reduce maternal morbidity and mortality, one of the most&#xD;
      influential being the &quot;Millennium Development Goals&quot;, now called &quot;Sustainable Development&#xD;
      Goals&quot;. Associated with these, national and regional public policies are developed that seek&#xD;
      to raise awareness about the importance of timely and early diagnosis, multidisciplinary and&#xD;
      synchronous management among several health areas with the aim of preventing and treating&#xD;
      obstetric hemorrhage to avoid fatal outcomes.&#xD;
&#xD;
      Within the prevention and management of obstetric bleeding, there are behaviors that have&#xD;
      shown significant impact on outcomes, such as, for example, the administration of uterotonics&#xD;
      in the active management of delivery, which reduce the risk of postpartum hemorrhage by up to&#xD;
      50% or the early administration of tranexamic acid, reducing mortality by 30%. However,&#xD;
      despite these advances, a fundamental part of the initial handling of support is the&#xD;
      volumetric resuscitation with crystalloids and in this field, although there is an indication&#xD;
      to initiate replenishment of losses it is not clear what type of liquid to use and if any&#xD;
      given their characteristics intrinsic can be superior to the other.&#xD;
&#xD;
      Justification In clinical practice, the goal of resuscitation is to return to cellular&#xD;
      homeostasis. Normal saline has been used for volumetric resuscitation for more than 50 years.&#xD;
      However, questions about its suitability have been raised given the association with negative&#xD;
      outcomes given its composition and question whether modifications in these would bring better&#xD;
      results. Multiple studies associated resuscitation with an unbalanced solution (normal&#xD;
      saline) with hyperchloremic acidosis, acute kidney injury and morbidity in general,&#xD;
      especially in the critically ill patient.&#xD;
&#xD;
      However, until now the evidence is not conclusive about whether this impact on the base acid&#xD;
      state, hydroelectrolytic imbalance, and potential kidney injury is less with &quot;balanced&quot;&#xD;
      solutions and generate better clinical results in all scenarios, surgical patients, patients&#xD;
      and particularly in hypovolemic shock due to obstetric hemorrhage.&#xD;
&#xD;
      Research question Are there differences in the volume of fluids and blood products to be used&#xD;
      in the outcomes of patients with obstetric hemorrhage with the use of balanced crystalloids&#xD;
      (Lactate Ringer or Plasma-Lyte) at the Hospital Universitario Santa Fe de Bogotá during the&#xD;
      years 2018 - 2019?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in the use of fluids and blood products</measure>
    <time_frame>2018 - 2019</time_frame>
    <description>Differences in the use of fluids and blood products with the use of balanced crystalloids in obstetric hemorrhage</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Lactate Ringer</arm_group_label>
    <description>Patients managed with Ringer Lactate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plasma-Lyte</arm_group_label>
    <description>Patients managed with Plasma-Lyte</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactate Ringer</intervention_name>
    <description>Patients managed with Lactate Ringer and obstetric hemorrhage</description>
    <arm_group_label>Lactate Ringer</arm_group_label>
    <other_name>Cristalloids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plasma-lyte</intervention_name>
    <description>Patients managed with Plasma-Lyte and obstetric hemorrhage</description>
    <arm_group_label>Plasma-Lyte</arm_group_label>
    <other_name>Balanced cristalloids</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Universe population: Patients with obstetric hemorrhage in the Hospital Universitario&#xD;
        Fundación Santa Fe de Bogotá.&#xD;
&#xD;
        Study population: Patients with obstetric hemorrhage at the Hospital Universitario&#xD;
        Fundación Santa Fe de Bogotá that meet the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of obstetric hemorrhage (&gt; 1000 mL). Over 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with incomplete clinical history.&#xD;
&#xD;
          -  Patients with active infections.&#xD;
&#xD;
          -  Patients with a history of blood dyscrasias.&#xD;
&#xD;
          -  Patients with known kidney disease.&#xD;
&#xD;
          -  Patient with previous alteration of the acid-base status.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leopoldo E Ferrer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Fundación Santa Fe de Bogotá</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leopoldo E Ferrer, M.D.</last_name>
    <phone>(57) 6030303</phone>
    <phone_ext>5016</phone_ext>
    <email>lfanesthesia@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guillermo A Madrid, M.D.</last_name>
    <phone>(57) 6030303</phone>
    <phone_ext>5016</phone_ext>
    <email>gamanesthesia@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Santa Fe de Bogotá</name>
      <address>
        <city>Bogotá</city>
        <zip>110111</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leopoldo E Ferrer, M.D.</last_name>
      <phone>6030303</phone>
      <phone_ext>5016</phone_ext>
      <email>lfanesthesia@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Santa Fe de Bogota</investigator_affiliation>
    <investigator_full_name>Leopoldo Ferrer</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>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plasma-lyte 148</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03824743
org study id: CCEI-9813-2018
nct id: NCT03824743
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Obstetric hemorrhage is the most feared complication that can occur during childbirth and
      continues to be the leading cause of death in pregnant women worldwide, about 7 women die
      every hour in the world. This is defined as an accumulated loss of blood of more than 1000 mL
      with signs and symptoms of hypovolemia within 24 hours of the birth process. The main
      objective of resuscitation in these patients is precisely to reduce the deleterious effects
      that are generated from the depletion of volume and the altered capacity of oxygen transport.
      The current debate focuses on the safety and efficacy of each particular liquid during
      resuscitation and on improving long-term patient outcomes. At present, there is no conclusive
      evidence on the impact at the level of acid-base status, hydroelectrolytic balance and
      potential kidney injury with respect to the use of balanced solutions such as Plasma-Lyte or
      Ringer's Lactate.

      Objective:

      To determine the differences in the volume of liquids and blood products required with the
      use of balanced crystalloids (Ringer's Lactate or Plasma-Lyte) in patients with obstetric
      hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá during 2018 - 2019.

      Design, Materials, and methods:

      Historical cohort analytical study. All patients over 18 years of age who present an
      obstetric hemorrhage defined as bleeding> 1000 mL or less associated with signs or symptoms
      of hemodynamic instability will be included. The most important exclusion criterion is the
      presence of active infection at the time of the event. Patients will be divided into two
      groups, those who underwent hydroelectrolytic resuscitation with Plasma-Lyte and Ringer
      Lactate.

      Results and conclusions With this study, we intend to describe the differences in the base
      acid status measured by arterial gases in patients with obstetric hemorrhage. The aim is to
      find a relationship between the different groups with clinical outcomes, such as days of ICU
      stay and hospitalization, blood transfusion requirement, electrolyte disorders, acute kidney
      injury and survival.
Problem Statement Maternal mortality is a tragic event with great social, economic and legal
      impact. The incidence rate varies depending on the source, however, it covers 400 cases per
      100,000 live births per year. The first cause of death in these patients is obstetric
      hemorrhage, which generates 150,000 deaths per year in the world. Not being outside of this
      situation, Bogotá presents a high number of women who present this complication, being the
      cause of death in 29% of cases in the years 2012 and 2013. Once this problem is identified,
      multiple strategies have sought to reduce maternal morbidity and mortality, one of the most
      influential being the "Millennium Development Goals", now called "Sustainable Development
      Goals". Associated with these, national and regional public policies are developed that seek
      to raise awareness about the importance of timely and early diagnosis, multidisciplinary and
      synchronous management among several health areas with the aim of preventing and treating
      obstetric hemorrhage to avoid fatal outcomes.

      Within the prevention and management of obstetric bleeding, there are behaviors that have
      shown significant impact on outcomes, such as, for example, the administration of uterotonics
      in the active management of delivery, which reduce the risk of postpartum hemorrhage by up to
      50% or the early administration of tranexamic acid, reducing mortality by 30%. However,
      despite these advances, a fundamental part of the initial handling of support is the
      volumetric resuscitation with crystalloids and in this field, although there is an indication
      to initiate replenishment of losses it is not clear what type of liquid to use and if any
      given their characteristics intrinsic can be superior to the other.

      Justification In clinical practice, the goal of resuscitation is to return to cellular
      homeostasis. Normal saline has been used for volumetric resuscitation for more than 50 years.
      However, questions about its suitability have been raised given the association with negative
      outcomes given its composition and question whether modifications in these would bring better
      results. Multiple studies associated resuscitation with an unbalanced solution (normal
      saline) with hyperchloremic acidosis, acute kidney injury and morbidity in general,
      especially in the critically ill patient.

      However, until now the evidence is not conclusive about whether this impact on the base acid
      state, hydroelectrolytic imbalance, and potential kidney injury is less with "balanced"
      solutions and generate better clinical results in all scenarios, surgical patients, patients
      and particularly in hypovolemic shock due to obstetric hemorrhage.

      Research question Are there differences in the volume of fluids and blood products to be used
      in the outcomes of patients with obstetric hemorrhage with the use of balanced crystalloids
      (Lactate Ringer or Plasma-Lyte) at the Hospital Universitario Santa Fe de Bogotá during the
      years 2018 - 2019?
observational model: Cohort
time perspective: Prospective
measure: Differences in the use of fluids and blood products
time frame: 2018 - 2019
description: Differences in the use of fluids and blood products with the use of balanced crystalloids in obstetric hemorrhage
arm group label: Lactate Ringer
description: Patients managed with Ringer Lactate
arm group label: Plasma-Lyte
description: Patients managed with Plasma-Lyte
intervention type: Drug
intervention name: Lactate Ringer
description: Patients managed with Lactate Ringer and obstetric hemorrhage
arm group label: Lactate Ringer
other name: Cristalloids
intervention type: Drug
intervention name: Plasma-lyte
description: Patients managed with Plasma-Lyte and obstetric hemorrhage
arm group label: Plasma-Lyte
other name: Balanced cristalloids
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leopoldo E Ferrer, M.D.
role: Principal Investigator
affiliation: Hospital Universitario Fundación Santa Fe de Bogotá
last name: Leopoldo E Ferrer, M.D.
phone: (57) 6030303
phone ext: 5016
email: lfanesthesia@gmail.com
last name: Guillermo A Madrid, M.D.
phone: (57) 6030303
phone ext: 5016
email: gamanesthesia@gmail.com
facility: 
status: Recruiting
contact: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Fundación Santa Fe de Bogota
investigator full name: Leopoldo Ferrer
investigator title: Principal investigator
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Plasma-lyte 148
sharing ipd: Undecided