<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/NCT03805542</url>
  </required_header>
  <id_info>
    <org_study_id>Tj-czq8366</org_study_id>
    <nct_id>NCT03805542</nct_id>
  </id_info>
  <brief_title>Treatment of Calculous Pyonephrosis With 0.5% Iodophors for I-stage PCNL</brief_title>
  <official_title>Instillation of Renal Pelvis With 0.5% Iodophors for Patients With Calculous Pyonephrosis for I-stage PCNL : a Multicentre, Prospective, Open, Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</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>
      Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in&#xD;
      clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on&#xD;
      the kidney function. Most stone operations can be performed in one stage, but there is still&#xD;
      some controversy about whether PCNL can be performed in first stage for calculous&#xD;
      pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce&#xD;
      pyuria caused by influenza, and then stone removal should be done in the second stage.&#xD;
      However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged&#xD;
      hospitalization, increased medical costs and increased family burden. Based on the current&#xD;
      treatment status of pyonephrosis patients, previous animal experimental results and&#xD;
      volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I&#xD;
      percutaneous nephrolithotomy(PCNL) after iodophor disinfection of renal collecting system.&#xD;
&#xD;
      Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants.&#xD;
      Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong&#xD;
      bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial&#xD;
      propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine&#xD;
      5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly&#xD;
      and persistently.&#xD;
&#xD;
      At present, clinical studies on calculous pyonephrosis at home and abroad are mostly&#xD;
      single-center, small sample studies, and lack of randomized controlled clinical trials. In&#xD;
      view of the current situation and animal experimental results, we intend to carry out a&#xD;
      clinical trial of &quot;iodophor treatment of pyonephrosis and one-stage operation&quot; in order to&#xD;
      benefit patients with calculous pyonephrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in&#xD;
      clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on&#xD;
      the kidney function. It can lead to renal failure and atrophy in the late stage. It can also&#xD;
      cause acute peritonitis due to pus penetrating the renal capsule and endanger life. Most&#xD;
      stone operations can be performed in first stage, but there is still some controversy about&#xD;
      whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea&#xD;
      is that nephrostomy should be performed first to induce pyuria caused by influenza, and then&#xD;
      stone removal should be done in the second stage. However, I-stage nephrostomy and drainage&#xD;
      and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs&#xD;
      and increased family burden. With the widespread use of the third and fourth generation&#xD;
      lithotripsy machines, ultrasound lithotripsy and lithotripsy system can reduce the pressure&#xD;
      in drainage system, which makes more and more urologists begin to try one-stage surgical&#xD;
      treatment for calculous pyonephrosis in non-acute infection period. Based on the current&#xD;
      treatment status of pyonephrosis patients, previous animal experimental results and&#xD;
      volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I&#xD;
      lithotripsy (PCNL) after iodophor disinfection of renal collecting system.&#xD;
&#xD;
      Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants.&#xD;
      Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong&#xD;
      bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial&#xD;
      propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine&#xD;
      5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly&#xD;
      and persistently. The principle of sterilization is to denaturate and precipitate proteins in&#xD;
      pathogenic organisms, leading to inactivation of bacteria and other microorganisms, so as to&#xD;
      achieve the purpose of efficient disinfection and sterilization.&#xD;
&#xD;
      It was found that the pharmacological action of iodophor solution containing 500 mg/L of&#xD;
      available iodine was to release iodine gradually, which had the characteristics of low&#xD;
      toxicity, little stimulation and long duration of pharmacodynamics. At present, 0.5% iodophor&#xD;
      is widely used in skin disinfection before surgery, its effectiveness and safety are&#xD;
      confirmed; intravenous drip of antibiotics one hour before surgery and 0.5% iodophor&#xD;
      irrigation during operation can significantly reduce the incidence of wound infection after&#xD;
      acute appendicitis surgery. In gynecological surgery, 0.5% iodophor is often used to&#xD;
      disinfect vaginal mucosa, and effective anti-infective effect is achieved.&#xD;
&#xD;
      It was found that routine iodophor irrigation of wounds for 2-3 minutes during operation&#xD;
      could effectively reduce the infection rate after operation, disinfect the skin area of&#xD;
      operation field, and the effect of iodophor solution could last until the end of routine&#xD;
      operation due to the slow release of iodine ions. Some researchers have studied the&#xD;
      toxicology of iodophor disinfectant and found that: (1) the LD50 （Lethal Does,50%）value of&#xD;
      animals tested in acute oral toxicity test is more than 5000mg/kg.bw, which is actually&#xD;
      non-toxic; (2) multiple skin irritation tests are non-irritating; (3) acute eye irritation&#xD;
      tests are non-irritating; (4) rabbit vaginal mucosa irritation index is extremely mild&#xD;
      irritation; (5) subacute toxicity tests suggest hematology and there was no statistical&#xD;
      difference between the blood biochemical indexes and the control group. Of course, people&#xD;
      allergic to iodine preparations are not allowed to use them. At present, there are many&#xD;
      reports about the application of iodophor solution in the disinfection of human mucosal&#xD;
      tissues. Domestic studies have reported that bladder irrigation with 20 ml 0.5% iodophor in&#xD;
      Intensive Care Unit(ICU) can prevent and treat bacterial and fungal infections in urinary&#xD;
      tract. Foreign studies have shown that 0.2% povidone iodine can replace 1% silver nitrate for&#xD;
      pelvic perfusion in chyluria patients (recurrence rate 9/22, or 22%; average follow-up 23.3&#xD;
      months). It should be noted that vaginal mucosal epithelium is a type of stratified flat&#xD;
      epithelium, which belongs to human stratified epithelium. Its surface layer is flat cells&#xD;
      with thick epithelium and has mechanical protective effect. The mucosal epithelium of renal&#xD;
      pelvis, ureter, bladder and urethra is a kind of transitional epithelium (also known as&#xD;
      metastatic epithelium), and also belongs to a kind of stratified epithelium. Its surface&#xD;
      layer is columnar cells, because of the shape of these epithelial cells. The shape and&#xD;
      hierarchy can change with the contraction or expansion of the organ, so they are named.&#xD;
      Transitional epithelium is characterized by dense cytoplasm near the lumen and strong&#xD;
      eosinophilic, forming a dark-stained shell, which can prevent the erosion of urine.&#xD;
      Therefore, there are some similarities and differences between the two types of epithelium,&#xD;
      which is of great significance for us to further study the application of iodophor in&#xD;
      transitional epithelium. At present, clinical studies on calculous pyonephrosis at home and&#xD;
      abroad are mostly single-center, small sample studies, and lack of randomized controlled&#xD;
      clinical trials. In view of the current situation and animal experimental results, we intend&#xD;
      to carry out a clinical trial of &quot;iodophor treatment of pyonephrosis and I-stage operation&quot;&#xD;
      in order to benefit patients with calculous pyonephrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2019</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of SIRS（Systemic inflammatory response syndrome）</measure>
    <time_frame>Day 3</time_frame>
    <description>Is there a statistical difference in the incidence of systemic inflammatory response syndrome between the control group and the experimental group?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Urosepsis</measure>
    <time_frame>Day 3</time_frame>
    <description>Is there a statistical difference in the incidence of urosepsis between the control group and the experimental group?</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">93</enrollment>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>I-stage nephrostomy（Double J stent placement under cystoscopy） and II-stage operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-stage operation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Disinfection of pelvis with 0.5% iodophors</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>0.5% Iodophors</intervention_name>
    <description>Before lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes.</description>
    <arm_group_label>I-stage operation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age (&gt;18) at the time of admission;&#xD;
&#xD;
          2. Glomerular filtration rate (GFR) &gt; 30 ml/min&#xD;
&#xD;
          3. Upper urinary tract calculi with ipsilateral pyogenic infection of renal collecting&#xD;
             system&#xD;
&#xD;
          4. No fear of cold and fever or low temperature(&lt;36°C) before operation;&#xD;
&#xD;
          5. According to the medical principle, PCNL treatment indications were given.&#xD;
&#xD;
          6. Leukocyte count was (4-12) 10^9/l. (Note: The above conditions should be met at the&#xD;
             same time.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Complicated with severe cardiopulmonary and cerebrovascular diseases, coagulation&#xD;
             dysfunction, hypertension, diabetes, etc.&#xD;
&#xD;
          2. iodine allergy;&#xD;
&#xD;
          3. lonely kidney or transplanted kidney;&#xD;
&#xD;
          4. Pregnancy patients;&#xD;
&#xD;
          5. those with hyperthyroidism, hypothyroidism or abnormal thyroid function;&#xD;
&#xD;
          6. Other matters that are taboo for operation.&#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_official>
    <last_name>Xinguang Wang, M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ph.D. Postgraduates</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhiqiang Chen, M.D.,Ph.D</last_name>
    <phone>+86 13995512271</phone>
    <email>zhqchen8366@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 4, 2019</last_update_submitted>
  <last_update_submitted_qc>August 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>calculous pyonephrosis</keyword>
  <keyword>I-stage PCNL</keyword>
  <keyword>iodophors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Pyonephrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03805542
org study id: Tj-czq8366
nct id: NCT03805542
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in
      clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on
      the kidney function. Most stone operations can be performed in one stage, but there is still
      some controversy about whether PCNL can be performed in first stage for calculous
      pyonephrosis. The traditional idea is that nephrostomy should be performed first to induce
      pyuria caused by influenza, and then stone removal should be done in the second stage.
      However, I-stage nephrostomy and drainage and II-stage lithotripsy can also lead to prolonged
      hospitalization, increased medical costs and increased family burden. Based on the current
      treatment status of pyonephrosis patients, previous animal experimental results and
      volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I
      percutaneous nephrolithotomy(PCNL) after iodophor disinfection of renal collecting system.

      Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants.
      Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong
      bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial
      propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine
      5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly
      and persistently.

      At present, clinical studies on calculous pyonephrosis at home and abroad are mostly
      single-center, small sample studies, and lack of randomized controlled clinical trials. In
      view of the current situation and animal experimental results, we intend to carry out a
      clinical trial of "iodophor treatment of pyonephrosis and one-stage operation" in order to
      benefit patients with calculous pyonephrosis.
Calculous Pyonephrosis is a special type of urinary tract calculi, which is also common in
      clinical practice. If pyonephrosis is not treated in time, it will have a serious impact on
      the kidney function. It can lead to renal failure and atrophy in the late stage. It can also
      cause acute peritonitis due to pus penetrating the renal capsule and endanger life. Most
      stone operations can be performed in first stage, but there is still some controversy about
      whether PCNL can be performed in first stage for calculous pyonephrosis. The traditional idea
      is that nephrostomy should be performed first to induce pyuria caused by influenza, and then
      stone removal should be done in the second stage. However, I-stage nephrostomy and drainage
      and II-stage lithotripsy can also lead to prolonged hospitalization, increased medical costs
      and increased family burden. With the widespread use of the third and fourth generation
      lithotripsy machines, ultrasound lithotripsy and lithotripsy system can reduce the pressure
      in drainage system, which makes more and more urologists begin to try one-stage surgical
      treatment for calculous pyonephrosis in non-acute infection period. Based on the current
      treatment status of pyonephrosis patients, previous animal experimental results and
      volunteers' blood iodine absorption status, we intend to design a clinical trial of Stage-I
      lithotripsy (PCNL) after iodophor disinfection of renal collecting system.

      Iodophor, also known as povidone iodine, is composed of iodine and polyol ether surfactants.
      Iodophor disinfectant is a disinfectant with iodine as its main ingredient. It has strong
      bactericidal power and broad antimicrobial spectrum. It can kill viruses, bacterial
      propagules, fungi, protozoa, etc. 0.5% iodophor disinfectant (containing effective iodine
      5000mg/L) can form a very thin bactericidal film on the wound surface and release it slowly
      and persistently. The principle of sterilization is to denaturate and precipitate proteins in
      pathogenic organisms, leading to inactivation of bacteria and other microorganisms, so as to
      achieve the purpose of efficient disinfection and sterilization.

      It was found that the pharmacological action of iodophor solution containing 500 mg/L of
      available iodine was to release iodine gradually, which had the characteristics of low
      toxicity, little stimulation and long duration of pharmacodynamics. At present, 0.5% iodophor
      is widely used in skin disinfection before surgery, its effectiveness and safety are
      confirmed; intravenous drip of antibiotics one hour before surgery and 0.5% iodophor
      irrigation during operation can significantly reduce the incidence of wound infection after
      acute appendicitis surgery. In gynecological surgery, 0.5% iodophor is often used to
      disinfect vaginal mucosa, and effective anti-infective effect is achieved.

      It was found that routine iodophor irrigation of wounds for 2-3 minutes during operation
      could effectively reduce the infection rate after operation, disinfect the skin area of
      operation field, and the effect of iodophor solution could last until the end of routine
      operation due to the slow release of iodine ions. Some researchers have studied the
      toxicology of iodophor disinfectant and found that: (1) the LD50 （Lethal Does,50%）value of
      animals tested in acute oral toxicity test is more than 5000mg/kg.bw, which is actually
      non-toxic; (2) multiple skin irritation tests are non-irritating; (3) acute eye irritation
      tests are non-irritating; (4) rabbit vaginal mucosa irritation index is extremely mild
      irritation; (5) subacute toxicity tests suggest hematology and there was no statistical
      difference between the blood biochemical indexes and the control group. Of course, people
      allergic to iodine preparations are not allowed to use them. At present, there are many
      reports about the application of iodophor solution in the disinfection of human mucosal
      tissues. Domestic studies have reported that bladder irrigation with 20 ml 0.5% iodophor in
      Intensive Care Unit(ICU) can prevent and treat bacterial and fungal infections in urinary
      tract. Foreign studies have shown that 0.2% povidone iodine can replace 1% silver nitrate for
      pelvic perfusion in chyluria patients (recurrence rate 9/22, or 22%; average follow-up 23.3
      months). It should be noted that vaginal mucosal epithelium is a type of stratified flat
      epithelium, which belongs to human stratified epithelium. Its surface layer is flat cells
      with thick epithelium and has mechanical protective effect. The mucosal epithelium of renal
      pelvis, ureter, bladder and urethra is a kind of transitional epithelium (also known as
      metastatic epithelium), and also belongs to a kind of stratified epithelium. Its surface
      layer is columnar cells, because of the shape of these epithelial cells. The shape and
      hierarchy can change with the contraction or expansion of the organ, so they are named.
      Transitional epithelium is characterized by dense cytoplasm near the lumen and strong
      eosinophilic, forming a dark-stained shell, which can prevent the erosion of urine.
      Therefore, there are some similarities and differences between the two types of epithelium,
      which is of great significance for us to further study the application of iodophor in
      transitional epithelium. At present, clinical studies on calculous pyonephrosis at home and
      abroad are mostly single-center, small sample studies, and lack of randomized controlled
      clinical trials. In view of the current situation and animal experimental results, we intend
      to carry out a clinical trial of "iodophor treatment of pyonephrosis and I-stage operation"
      in order to benefit patients with calculous pyonephrosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of SIRS（Systemic inflammatory response syndrome）
time frame: Day 3
description: Is there a statistical difference in the incidence of systemic inflammatory response syndrome between the control group and the experimental group?
measure: Incidence of Urosepsis
time frame: Day 3
description: Is there a statistical difference in the incidence of urosepsis between the control group and the experimental group?
arm group label: Control group
arm group type: No Intervention
description: I-stage nephrostomy（Double J stent placement under cystoscopy） and II-stage operation
arm group label: I-stage operation group
arm group type: Experimental
description: Disinfection of pelvis with 0.5% iodophors
intervention type: Combination Product
intervention name: 0.5% Iodophors
description: Before lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes.
arm group label: I-stage operation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xinguang Wang, M.A.
role: Principal Investigator
affiliation: Ph.D. Postgraduates
last name: Zhiqiang Chen, M.D.,Ph.D
phone: +86 13995512271
email: zhqchen8366@163.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Urolithiasis
mesh term: Pyonephrosis
sharing ipd: No