<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/NCT02974946</url>
  </required_header>
  <id_info>
    <org_study_id>2016CAR88</org_study_id>
    <nct_id>NCT02974946</nct_id>
  </id_info>
  <brief_title>Kidney Protection Using the RenalGuard® System in Cardiac Surgery</brief_title>
  <acronym>KIDNEY</acronym>
  <official_title>Kidney Protection Using the RenalGuard® System in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Royal Wolverhampton Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Royal Wolverhampton Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomised control trial 1:1 in patients at risk of developing Acute&#xD;
      Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical&#xD;
      treatment. 110 patients will be recruited for each group. The aim of the study is to assess&#xD;
      whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as&#xD;
      compared to current practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing elective or in-house urgent cardiac surgery will be approached for the&#xD;
      KIDNEY study if they fulfil the inclusion criteria. Upon consent pre-operative blood tests&#xD;
      will be as per the usual practice. Moreover, 2ml of the serum will be stored for NGAL&#xD;
      analysis.&#xD;
&#xD;
      Following the consenting process, patients will be randomised (envelop- based) into either&#xD;
      having the RenalGuard® System (Study group) or current medical management (Control group).&#xD;
&#xD;
      Study group:&#xD;
&#xD;
      Patients in the study group will have the RenalGuard® System started in anaesthetic room once&#xD;
      the peripheral line and arterial lines are sited. The RenalGuard® System will continue to run&#xD;
      throughout the cardiac procedure in the operating room and up to 6 hours post-op after the&#xD;
      patient has been transferred to the unit. Patients will be managed at a zero balance i.e.&#xD;
      volume of the urine output will be matched to the volume of Hartmann's fluid infusion. Forced&#xD;
      diuresis is then initiated.&#xD;
&#xD;
      Control group:&#xD;
&#xD;
      Patients in the control group will be managed as per current medical practice which will&#xD;
      include no forced diuresis in operating room and the use of inotropes for maintenance of mean&#xD;
      arterial pressure and intravenous furosemide for diuresis.&#xD;
&#xD;
      An additional blood test (NGAL) at six hours post-op will be taken and would require 2mls of&#xD;
      blood. The NGAL specimens will be dealt with by the biochemistry lab (centrifuged &amp; stored)&#xD;
      so that the specimens can be analysed in batches.&#xD;
&#xD;
      Patients kidney function (U&amp;Es) will be tested at the time of post-operatively as per usual&#xD;
      practice (Day1, pre-discharge and as clinically indicated) and at the post-operative surgical&#xD;
      out-patient visit.&#xD;
&#xD;
      Pre-operative, intra-operative and post-operative data will be collected for each patient&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 22, 2019</completion_date>
  <primary_completion_date type="Actual">June 12, 2019</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>Incidence of AKI as defined by the RIFLE criteria</measure>
    <time_frame>50% rise in pre-op serum creatinine within 3 days of surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Acute Renal Injury</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the RenalGuard system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard practice will be performed with no RenalGuard system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RenalGuard</intervention_name>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing surgery (elective or in-house urgent)&#xD;
&#xD;
          2. Patient 18 years old and over&#xD;
&#xD;
          3. Patient able to give written consent&#xD;
&#xD;
          4. Patient at risk of developing AKI after cardiac surgery (at least one factor)&#xD;
&#xD;
               1. Diabetics (IDDM or NIDDM) with normal kidney function pre-op&#xD;
&#xD;
               2. Patients with eGFR 20-60&#xD;
&#xD;
               3. Patients undergoing combined cardiac procedures when the CPB time is likely to&#xD;
                  exceed 120 minutes&#xD;
&#xD;
               4. Patients with Hb of 12.5 g/dl or below&#xD;
&#xD;
               5. Logistic Euroscore of 5 and above&#xD;
&#xD;
          5. Patient not involved with another study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Emergency surgery&#xD;
&#xD;
          2. Patient unable to give written consent&#xD;
&#xD;
          3. Patient already dialysis dependent or eGFR &lt;20&#xD;
&#xD;
          4. Patient partaking in another study&#xD;
&#xD;
          5. Pregnant patients&#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>Heyman Luckraz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Wolverhampton NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Wolverhampton NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <state>West Midlands</state>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.</citation>
    <PMID>33236105</PMID>
  </results_reference>
  <results_reference>
    <citation>Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels. J Cardiothorac Surg. 2021 Aug 24;16(1):240. doi: 10.1186/s13019-021-01620-w.</citation>
    <PMID>34429137</PMID>
  </results_reference>
  <results_reference>
    <citation>Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131. doi: 10.1111/jocs.15925. Epub 2021 Aug 19.</citation>
    <PMID>34414606</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</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/NCT02974946
org study id: 2016CAR88
nct id: NCT02974946
lead sponsor: 
has dmc: Yes
This is a prospective randomised control trial 1:1 in patients at risk of developing Acute
      Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical
      treatment. 110 patients will be recruited for each group. The aim of the study is to assess
      whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as
      compared to current practice.
Patients undergoing elective or in-house urgent cardiac surgery will be approached for the
      KIDNEY study if they fulfil the inclusion criteria. Upon consent pre-operative blood tests
      will be as per the usual practice. Moreover, 2ml of the serum will be stored for NGAL
      analysis.

      Following the consenting process, patients will be randomised (envelop- based) into either
      having the RenalGuard® System (Study group) or current medical management (Control group).

      Study group:

      Patients in the study group will have the RenalGuard® System started in anaesthetic room once
      the peripheral line and arterial lines are sited. The RenalGuard® System will continue to run
      throughout the cardiac procedure in the operating room and up to 6 hours post-op after the
      patient has been transferred to the unit. Patients will be managed at a zero balance i.e.
      volume of the urine output will be matched to the volume of Hartmann's fluid infusion. Forced
      diuresis is then initiated.

      Control group:

      Patients in the control group will be managed as per current medical practice which will
      include no forced diuresis in operating room and the use of inotropes for maintenance of mean
      arterial pressure and intravenous furosemide for diuresis.

      An additional blood test (NGAL) at six hours post-op will be taken and would require 2mls of
      blood. The NGAL specimens will be dealt with by the biochemistry lab (centrifuged & stored)
      so that the specimens can be analysed in batches.

      Patients kidney function (U&Es) will be tested at the time of post-operatively as per usual
      practice (Day1, pre-discharge and as clinically indicated) and at the post-operative surgical
      out-patient visit.

      Pre-operative, intra-operative and post-operative data will be collected for each patient
      group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of AKI as defined by the RIFLE criteria
time frame: 50% rise in pre-op serum creatinine within 3 days of surgery
arm group label: Study group
arm group type: Experimental
description: Patients will receive the RenalGuard system
arm group label: Control group
arm group type: No Intervention
description: Standard practice will be performed with no RenalGuard system
intervention type: Device
intervention name: RenalGuard
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heyman Luckraz
role: Principal Investigator
affiliation: Royal Wolverhampton NHS Trust
facility: 
country: United Kingdom
citation: Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
PMID: 33236105
citation: Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis compared to control as a reno-protective approach in cardiac surgery: secondary outcome of a randomized controlled trial, assessment of neutrophil gelatinase-associated lipocalin levels. J Cardiothorac Surg. 2021 Aug 24;16(1):240. doi: 10.1186/s13019-021-01620-w.
PMID: 34429137
citation: Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131. doi: 10.1111/jocs.15925. Epub 2021 Aug 19.
PMID: 34414606
responsible party type: Sponsor
mesh term: Acute Kidney Injury