<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/NCT02232997</url>
  </required_header>
  <id_info>
    <org_study_id>CSC20140818</org_study_id>
    <secondary_id>CSC20140818</secondary_id>
    <nct_id>NCT02232997</nct_id>
  </id_info>
  <brief_title>Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease</brief_title>
  <acronym>TIME</acronym>
  <official_title>The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The General Hospital of Northern Theater Command</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiamen Cardiovascular Hospital, Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Asia Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jining Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fuling Central Hospital of Chongqing City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Guangxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maoming People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tangshan Gongren Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuzhou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southern Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      No well-defined protocols exist to guide fluid administration for prevention of&#xD;
      contrast-associated acute kidney injury in high risk patients. The investigators will compare&#xD;
      long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short&#xD;
      term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our&#xD;
      hypothesis that the short term hydration may not be inferior to the long one.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No well-defined protocols exist to guide fluid administration for prevention of&#xD;
      contrast-associated acute kidney injury in high risk patients undergoing coronary&#xD;
      angiography. Long term hydration at routine speed(12h before and after procedure at&#xD;
      1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent&#xD;
      contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the&#xD;
      POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term&#xD;
      hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to&#xD;
      the classic long term hydration, the speed should be reduced half of the intended speed in&#xD;
      all the patients. We hypothesized short term hydration may not be inferior to the long one to&#xD;
      reduced significantly the hospital stay and healthy cost.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contrast-associated acute kidney injury a</measure>
    <time_frame>72 hours</time_frame>
    <description>Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Acute heart failure</measure>
    <time_frame>post-procedural during hospitalization, an average of 3 days</time_frame>
    <description>Defined as signs/symptoms of heart congestion and/or hypoperfusion by physical examination and auxiliary examination such as ECG, chest X-ray, laboratory assessment (biomarkers and echocardiography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-associated acute kidney injury b</measure>
    <time_frame>72 hours</time_frame>
    <description>Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-associated acute kidney injury c</measure>
    <time_frame>24 hours</time_frame>
    <description>Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-associated acute kidney injury d</measure>
    <time_frame>48 hours</time_frame>
    <description>Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-associated acute kidney injury e</measure>
    <time_frame>24 hours</time_frame>
    <description>Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse clinical events</measure>
    <time_frame>1 year</time_frame>
    <description>Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eGFR a</measure>
    <time_frame>72 hours</time_frame>
    <description>Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eGFR b</measure>
    <time_frame>72 hours</time_frame>
    <description>Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-induced persistence kidney injury</measure>
    <time_frame>3 months</time_frame>
    <description>Defined as residual impairment of renal function indicated by a &gt;25% reduction in creatinine clearance in comparison with the baseline value or dialysis requirement at 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>an average of 7 days</time_frame>
    <description>Total length of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospitalization costs</measure>
    <time_frame>an average of 7 days</time_frame>
    <description>Hospitalization expenses during hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1002</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Standard Hydration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simplified Hydration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Hydration</intervention_name>
    <description>Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class&gt;II, or LVEF &lt; 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg</description>
    <arm_group_label>Standard Hydration</arm_group_label>
    <other_name>The control hydration group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simplified Hydration</intervention_name>
    <description>Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class&gt;II, or LVEF &lt;35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.</description>
    <arm_group_label>Simplified Hydration</arm_group_label>
    <other_name>The simple hydration group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age;&#xD;
&#xD;
          -  Written informed consent;&#xD;
&#xD;
          -  Candidates scheduled for coronary intervention (angiography and/or coronary&#xD;
             intervention);&#xD;
&#xD;
          -  Patients with chronic renal insufficiency, the baseline estimated glomerular&#xD;
             filtration rate (eGFR) was 15-60 mL/min / 1.73 m²&#xD;
&#xD;
          -  At least one risk factor (age&gt;75 years, medical history of diabetes mellitus or&#xD;
             hypertension, congestive heart failure [NYHA class &gt;II or history of acute pulmonary&#xD;
             edema]);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End-stage renal failure or heart/renal transplantation;&#xD;
&#xD;
          -  History of exposure to contrast medium or acute infectious diseases within 48 hours&#xD;
             prior to the procedure;&#xD;
&#xD;
          -  Acute decompensated heart failure;&#xD;
&#xD;
          -  Left ventricular thrombus;&#xD;
&#xD;
          -  Allergy to contrast agent;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Malignant tumour or life expectancy &lt;1 year;&#xD;
&#xD;
          -  Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or&#xD;
             cisplatin in the past 48 h;&#xD;
&#xD;
          -  Severe valve disease or elective undergoing surgery.&#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>Jiyan Chen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong Liu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong Huo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Junbo Ge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pingyan Chen, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>501080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>Jiyan Chen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Contrast-associated acute kidney injury</keyword>
  <keyword>Coronary angiography</keyword>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Intravenous hydration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_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/NCT02232997
org study id: CSC20140818
secondary id: CSC20140818
nct id: NCT02232997
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
No well-defined protocols exist to guide fluid administration for prevention of
      contrast-associated acute kidney injury in high risk patients. The investigators will compare
      long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short
      term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our
      hypothesis that the short term hydration may not be inferior to the long one.
No well-defined protocols exist to guide fluid administration for prevention of
      contrast-associated acute kidney injury in high risk patients undergoing coronary
      angiography. Long term hydration at routine speed(12h before and after procedure at
      1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent
      contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the
      POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term
      hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to
      the classic long term hydration, the speed should be reduced half of the intended speed in
      all the patients. We hypothesized short term hydration may not be inferior to the long one to
      reduced significantly the hospital stay and healthy cost.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Contrast-associated acute kidney injury a
time frame: 72 hours
description: Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
measure: Number of Participants with Acute heart failure
time frame: post-procedural during hospitalization, an average of 3 days
description: Defined as signs/symptoms of heart congestion and/or hypoperfusion by physical examination and auxiliary examination such as ECG, chest X-ray, laboratory assessment (biomarkers and echocardiography)
measure: Contrast-associated acute kidney injury b
time frame: 72 hours
description: Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure
measure: Contrast-associated acute kidney injury c
time frame: 24 hours
description: Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
measure: Contrast-associated acute kidney injury d
time frame: 48 hours
description: Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure
measure: Contrast-associated acute kidney injury e
time frame: 24 hours
description: Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure
measure: Major adverse clinical events
time frame: 1 year
description: Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
measure: Change in eGFR a
time frame: 72 hours
description: Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
measure: Change in eGFR b
time frame: 72 hours
description: Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
measure: Contrast-induced persistence kidney injury
time frame: 3 months
description: Defined as residual impairment of renal function indicated by a >25% reduction in creatinine clearance in comparison with the baseline value or dialysis requirement at 3 months
measure: Length of stay
time frame: an average of 7 days
description: Total length of hospital stay
measure: Total hospitalization costs
time frame: an average of 7 days
description: Hospitalization expenses during hospitalization
arm group label: Standard Hydration
arm group type: Active Comparator
description: Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h
arm group label: Simplified Hydration
arm group type: Active Comparator
description: Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h
intervention type: Other
intervention name: Standard Hydration
description: Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF < 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg
arm group label: Standard Hydration
other name: The control hydration group
intervention type: Other
intervention name: Simplified Hydration
description: Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF <35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.
arm group label: Simplified Hydration
other name: The simple hydration group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiyan Chen, MD
role: Study Chair
affiliation: Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
last name: Yong Liu, MD
role: Study Director
affiliation: Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital
last name: Yong Huo, MD
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Junbo Ge, MD
role: Principal Investigator
affiliation: Fudan University
last name: Pingyan Chen, MS
role: Principal Investigator
affiliation: Southern Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: Jiyan Chen
investigator title: MD
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic