<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/NCT01670604</url>
  </required_header>
  <id_info>
    <org_study_id>KAH012</org_study_id>
    <nct_id>NCT01670604</nct_id>
  </id_info>
  <brief_title>Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures</brief_title>
  <official_title>The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the effect of infusion of two types of modern hydroxyethyl starch on the&#xD;
      renal function and acid-base in patients undergoing urologic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>Phase 4</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative volume replacement therapy</measure>
    <time_frame>From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours</time_frame>
    <description>volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acid base and Renal function</measure>
    <time_frame>24 hours after randomization</time_frame>
    <description>differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Urologic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>VOL group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TET group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient will receive 6% HES 130/0.42 in a balanced electrolyte containing Na+140 mmol/L, Cl- 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)</intervention_name>
    <arm_group_label>VOL group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tetraspan, B. Braun, Melsungen, Germany</intervention_name>
    <arm_group_label>TET group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age group above 18 years,&#xD;
&#xD;
          -  ASA І and ІІ,&#xD;
&#xD;
          -  Patients who will be scheduled to undergo radical prostatectomy or cystectomy with&#xD;
             bladder replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known allergy to HES,&#xD;
&#xD;
          -  Renal insufﬁciency (serum creatinine of &gt;2.5 mg/dL),&#xD;
&#xD;
          -  Signiﬁcant hepatic disease (liver function tests more than three times the upper limit&#xD;
             of normal),&#xD;
&#xD;
          -  Coagulation disorders (INR &gt; 1.5).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amr Hussein, MSc</last_name>
    <phone>01069338998</phone>
    <phone_ext>+2</phone_ext>
    <email>amrhussein1981@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Mukhtar, MD</last_name>
    <phone>01114208444</phone>
    <phone_ext>+2</phone_ext>
    <email>Ahmed.Mukhtar@kasralainy.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasralainy Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11559</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amr Hussein, MSc</last_name>
      <phone>01069338998</phone>
      <phone_ext>+2</phone_ext>
      <email>amrhussein1981@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Abeer Ahmed, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nazmy Seif, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Helmy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Mukhtar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amr Hussein, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Kluft C, Jenks RL, Astrup T. Production of plasminogen actovatpr activity in factor XII-deficient plasma. Thromb Res. 1977 May;10(5):759-64. doi: 10.1016/0049-3848(77)90058-5. No abstract available.</citation>
    <PMID>18813</PMID>
  </reference>
  <reference>
    <citation>Takayanagi I, Maruyama M, Takagi K. Beta-adrenoceptors in the guinea pig treated with egg-albumin. Jpn J Pharmacol. 1977 Apr;27(2):314-6. doi: 10.1254/jjp.27.314. No abstract available.</citation>
    <PMID>18633</PMID>
  </reference>
  <reference>
    <citation>Mitchell AR, Erickson BW, Ryabtsev MN, Hodges RS, Merrifield RB. Tert-butoxycarbonylaminoacyl-4-(oxymethyl)-phenylacetamidomethyl-resin, a more acid-resistant support for solid-phase peptide synthesis. J Am Chem Soc. 1976 Nov 10;98(23):7357-62. doi: 10.1021/ja00439a041. No abstract available.</citation>
    <PMID>10319</PMID>
  </reference>
  <reference>
    <citation>Birke ER. [On the action of antihypotensive agents in sympathicotonic orthostatic hypotension in geriartric patients: comparison between placebo and etilefrin (author's transl)]. Med Klin. 1977 Oct 14;72(41):1696-702. German.</citation>
    <PMID>21345</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Mukhtar</investigator_full_name>
    <investigator_title>Assistant professor of anesthesia Cairo University</investigator_title>
  </responsible_party>
  <!-- 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/NCT01670604
org study id: KAH012
nct id: NCT01670604
lead sponsor: 
has dmc: Yes
This study compares the effect of infusion of two types of modern hydroxyethyl starch on the
      renal function and acid-base in patients undergoing urologic surgery.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Intraoperative volume replacement therapy
time frame: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours
description: volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point).
measure: Acid base and Renal function
time frame: 24 hours after randomization
description: differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups
arm group label: VOL group
arm group type: Experimental
description: patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
arm group label: TET group
arm group type: Experimental
description: patient will receive 6% HES 130/0.42 in a balanced electrolyte containing Na+140 mmol/L, Cl- 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L
intervention type: Drug
intervention name: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
arm group label: VOL group
intervention type: Drug
intervention name: Tetraspan, B. Braun, Melsungen, Germany
arm group label: TET group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Amr Hussein, MSc
phone: 01069338998
phone ext: +2
email: amrhussein1981@hotmail.com
last name: Ahmed Mukhtar, MD
phone: 01114208444
phone ext: +2
email: Ahmed.Mukhtar@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: Kluft C, Jenks RL, Astrup T. Production of plasminogen actovatpr activity in factor XII-deficient plasma. Thromb Res. 1977 May;10(5):759-64. doi: 10.1016/0049-3848(77)90058-5. No abstract available.
PMID: 18813
citation: Takayanagi I, Maruyama M, Takagi K. Beta-adrenoceptors in the guinea pig treated with egg-albumin. Jpn J Pharmacol. 1977 Apr;27(2):314-6. doi: 10.1254/jjp.27.314. No abstract available.
PMID: 18633
citation: Mitchell AR, Erickson BW, Ryabtsev MN, Hodges RS, Merrifield RB. Tert-butoxycarbonylaminoacyl-4-(oxymethyl)-phenylacetamidomethyl-resin, a more acid-resistant support for solid-phase peptide synthesis. J Am Chem Soc. 1976 Nov 10;98(23):7357-62. doi: 10.1021/ja00439a041. No abstract available.
PMID: 10319
citation: Birke ER. [On the action of antihypotensive agents in sympathicotonic orthostatic hypotension in geriartric patients: comparison between placebo and etilefrin (author's transl)]. Med Klin. 1977 Oct 14;72(41):1696-702. German.
PMID: 21345
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Ahmed Mukhtar
investigator title: Assistant professor of anesthesia Cairo University