<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/NCT01704482</url>
  </required_header>
  <id_info>
    <org_study_id>tafanono01003060187</org_study_id>
    <nct_id>NCT01704482</nct_id>
  </id_info>
  <brief_title>N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement</brief_title>
  <official_title>N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <brief_summary>
    <textblock>
      We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal&#xD;
      dysfunction in patients with rheumatic valvular heart disease undergoing single valve&#xD;
      replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 2</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>Absolute change in serum creatinine from baseline to peak level</measure>
    <time_frame>within 5 days after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the relative change in serum creatinine.</measure>
    <time_frame>the first five postoperative days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the urinary output</measure>
    <time_frame>the first five postoperative days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiac Surgery for Rheumatic Valvular Heart Disease</condition>
  <condition>Renal Dysfunction</condition>
  <arm_group>
    <arm_group_label>N-acetylcysteine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose 5%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>equivalent volume over the same period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetylcysteine</intervention_name>
    <description>NAC bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs</description>
    <arm_group_label>N-acetylcysteine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Glucose 5%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with rheumatic heart disease undergoing single valve replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)&#xD;
&#xD;
          -  Emergency cardiac surgery&#xD;
&#xD;
          -  Planned off-pump cardiac surgery&#xD;
&#xD;
          -  Chronic inflammatory disease on immunosuppression&#xD;
&#xD;
          -  Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or&#xD;
             equivalent)&#xD;
&#xD;
          -  Age ≤ 18 years.&#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>Laila H Mohamed, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut university hosiptal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nawal A Gad El-rab, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut university hosiptal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fatma A Abd El-Aal, Ass Prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut university hosiptal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University hospital</name>
      <address>
        <city>Assiut</city>
        <zip>11111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mostafa Samy Abbas</investigator_full_name>
    <investigator_title>assistant lecturer of anesthesia and ICU, Assiut University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Heart Disease</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</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/NCT01704482
org study id: tafanono01003060187
nct id: NCT01704482
lead sponsor: 
We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal
      dysfunction in patients with rheumatic valvular heart disease undergoing single valve
      replacement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Absolute change in serum creatinine from baseline to peak level
time frame: within 5 days after surgery
measure: the relative change in serum creatinine.
time frame: the first five postoperative days
measure: the urinary output
time frame: the first five postoperative days
arm group label: N-acetylcysteine
arm group type: Experimental
description: N-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs
arm group label: Glucose 5%
arm group type: Placebo Comparator
description: equivalent volume over the same period.
intervention type: Drug
intervention name: N-acetylcysteine
description: NAC bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs
arm group label: N-acetylcysteine
intervention type: Drug
intervention name: placebo
arm group label: Glucose 5%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laila H Mohamed, Prof
role: Study Chair
affiliation: Assiut university hosiptal
last name: Nawal A Gad El-rab, Prof
role: Study Director
affiliation: Assiut university hosiptal
last name: Fatma A Abd El-Aal, Ass Prof
role: Study Director
affiliation: Assiut university hosiptal
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mostafa Samy Abbas
investigator title: assistant lecturer of anesthesia and ICU, Assiut University
mesh term: Rheumatic Heart Disease
mesh term: Rheumatic Diseases
mesh term: Renal Insufficiency
mesh term: Heart Diseases
mesh term: Heart Valve Diseases
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine