<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/NCT04465539</url>
  </required_header>
  <id_info>
    <org_study_id>HES &amp; hydrocortisone</org_study_id>
    <nct_id>NCT04465539</nct_id>
  </id_info>
  <brief_title>The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning</brief_title>
  <official_title>The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</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>
      Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is&#xD;
      available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each&#xD;
      tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The&#xD;
      incidence of ALP poisoning increased steadily specially in developing countries . ALP&#xD;
      poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide&#xD;
      accessibility and low cost. However, accidental poisoning may occur during occupational&#xD;
      exposure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is&#xD;
      available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each&#xD;
      tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The&#xD;
      incidence of ALP poisoning increased steadily specially in developing countries . ALP&#xD;
      poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide&#xD;
      accessibility and low cost. However, accidental poisoning may occur during occupational&#xD;
      exposure.&#xD;
&#xD;
      Signs and symptoms of acute AlP poisoning include gastrointestinal, cardiovascular, hepatic,&#xD;
      renal, and neurologic (1). Ingestion of ALP causes mild gastrointestinal (GIT) manifestations&#xD;
      as nausea, vomiting, abdominal pain, in addition to chest tightness, hypotension, headache&#xD;
      and dizziness. In severe cases, GIT hemorrhage, shock, severe metabolic acidosis, cardiac&#xD;
      arrhythmia, convulsions and coma may occur. Later, signs of hepatic damage and renal&#xD;
      insufficiency may develop.&#xD;
&#xD;
      Death usually occurs in 30-70% of cases within the first 24 hours resulting from refractory&#xD;
      cardiogenic shock, cardiac arrhythmia, severe hypotension and metabolic acidosis.The main&#xD;
      causes of cardiovascular collapse are increase capillary permeability, insufficient systemic&#xD;
      vasoconstriction with low ventricular ejection fraction. On autopsy examinations, point to&#xD;
      extravasation of fluid into the third space.&#xD;
&#xD;
      The management is exclusively supportive as gastric lavage with KMnO4 solution, treatment of&#xD;
      hypotension and acidosis in view of the fact that there is no specific antidote available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>28 days from start of management</time_frame>
    <description>mortality rate of patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for mechanical ventilation</measure>
    <time_frame>Through study completion up to 6 months</time_frame>
    <description>incidence of need for intubation and mechanical ventilation for each patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for ICU admission</measure>
    <time_frame>Through study completion up to 6 months</time_frame>
    <description>the incidence of need for ICU admission for each patient</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Potential Therapeutic Role</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydroxyethyl starch group):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will start therapy with Hydroxyethyl starch instead of normal saline (6% hetastarch 600/0.75 in 0.9% sodium chloride) with a dose of 500 cc in 6 hours. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Hydroxyethyl starch and hydrocortisone group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will start therapy with combined Hydroxyethyl starch (Voluven®, fresenius kabi, Germany) and hydrocortisone (SOLU-CORTEF 100 mg ampoule) instead of normal saline of normal saline as follow: Hydroxyethyl starch dose is 6% hetastarch 600/0.75 in 0.9% sodium chloride with a dose of 500 cc in 6 hours. Hydrocortisone dose is 200-300 mg /day intravenously until normalization of blood pressure. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]</intervention_name>
    <description>Hydroxyethyl starch dose is 500 cc in 6 hours</description>
    <arm_group_label>Combined Hydroxyethyl starch and hydrocortisone group</arm_group_label>
    <arm_group_label>Hydroxyethyl starch group):</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone</intervention_name>
    <description>Hydrocortisone dose is 200-300 mg /day intravenously</description>
    <arm_group_label>Combined Hydroxyethyl starch and hydrocortisone group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.</description>
    <arm_group_label>Combined Hydroxyethyl starch and hydrocortisone group</arm_group_label>
    <arm_group_label>Hydroxyethyl starch group):</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with severe acute aluminum phosphide poisoning&#xD;
&#xD;
          -  systolic blood pressure (SBP) ≤90 mmHg&#xD;
&#xD;
          -  PH ≤ 7.2&#xD;
&#xD;
          -  HCO3 ≤15 meq/L&#xD;
&#xD;
          -  during the first six hours of admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Asymptomatic patients with history of acute aluminum phosphide exposure.&#xD;
&#xD;
          -  Patients with co-ingestion to other substances in addition to aluminum phosphide.&#xD;
&#xD;
          -  Patients with other major medical conditions (e.g. cardiovascular disease, renal or&#xD;
             hepatic failure).&#xD;
&#xD;
          -  Patients with previous medical intervention (fluid therapy and vasopressors).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tarek Abdel Hay</name>
      <address>
        <city>Tanta</city>
        <state>El Gharbyia</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>tarek abdelhay mostafa, MD</last_name>
      <phone>0201003591332</phone>
      <email>dr.tarek311@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>tarek abdel hay mostafa</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Hydroxyethyl Starch Derivatives</mesh_term>
  </intervention_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/NCT04465539
org study id: HES & hydrocortisone
nct id: NCT04465539
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is
      available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each
      tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The
      incidence of ALP poisoning increased steadily specially in developing countries . ALP
      poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide
      accessibility and low cost. However, accidental poisoning may occur during occupational
      exposure
Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is
      available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each
      tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The
      incidence of ALP poisoning increased steadily specially in developing countries . ALP
      poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide
      accessibility and low cost. However, accidental poisoning may occur during occupational
      exposure.

      Signs and symptoms of acute AlP poisoning include gastrointestinal, cardiovascular, hepatic,
      renal, and neurologic (1). Ingestion of ALP causes mild gastrointestinal (GIT) manifestations
      as nausea, vomiting, abdominal pain, in addition to chest tightness, hypotension, headache
      and dizziness. In severe cases, GIT hemorrhage, shock, severe metabolic acidosis, cardiac
      arrhythmia, convulsions and coma may occur. Later, signs of hepatic damage and renal
      insufficiency may develop.

      Death usually occurs in 30-70% of cases within the first 24 hours resulting from refractory
      cardiogenic shock, cardiac arrhythmia, severe hypotension and metabolic acidosis.The main
      causes of cardiovascular collapse are increase capillary permeability, insufficient systemic
      vasoconstriction with low ventricular ejection fraction. On autopsy examinations, point to
      extravasation of fluid into the third space.

      The management is exclusively supportive as gastric lavage with KMnO4 solution, treatment of
      hypotension and acidosis in view of the fact that there is no specific antidote available.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: mortality
time frame: 28 days from start of management
description: mortality rate of patients
measure: Need for mechanical ventilation
time frame: Through study completion up to 6 months
description: incidence of need for intubation and mechanical ventilation for each patient
measure: need for ICU admission
time frame: Through study completion up to 6 months
description: the incidence of need for ICU admission for each patient
arm group label: control group
arm group type: Placebo Comparator
description: received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.
arm group label: Hydroxyethyl starch group):
arm group type: Experimental
description: Patients will start therapy with Hydroxyethyl starch instead of normal saline (6% hetastarch 600/0.75 in 0.9% sodium chloride) with a dose of 500 cc in 6 hours. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo.
arm group label: Combined Hydroxyethyl starch and hydrocortisone group
arm group type: Experimental
description: Patients will start therapy with combined Hydroxyethyl starch (Voluven®, fresenius kabi, Germany) and hydrocortisone (SOLU-CORTEF 100 mg ampoule) instead of normal saline of normal saline as follow: Hydroxyethyl starch dose is 6% hetastarch 600/0.75 in 0.9% sodium chloride with a dose of 500 cc in 6 hours. Hydrocortisone dose is 200-300 mg /day intravenously until normalization of blood pressure. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo.
intervention type: Drug
intervention name: Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]
description: Hydroxyethyl starch dose is 500 cc in 6 hours
arm group label: Combined Hydroxyethyl starch and hydrocortisone group
arm group label: Hydroxyethyl starch group):
intervention type: Drug
intervention name: Hydrocortisone
description: Hydrocortisone dose is 200-300 mg /day intravenously
arm group label: Combined Hydroxyethyl starch and hydrocortisone group
intervention type: Drug
intervention name: Placebo
description: received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.
arm group label: Combined Hydroxyethyl starch and hydrocortisone group
arm group label: Hydroxyethyl starch group):
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: tarek abdel hay mostafa
investigator title: principle investigator
mesh term: Poisoning
mesh term: Hydrocortisone
mesh term: Hydroxyethyl Starch Derivatives