<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/NCT04507672</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZDSYLL105-P01</org_study_id>
    <nct_id>NCT04507672</nct_id>
  </id_info>
  <brief_title>Acetated Ringer's Solution Versus Saline in Patients With Septic Shock</brief_title>
  <official_title>Acetated Ringer's Solution Versus Saline in Patients With Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>No</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>
      The primary aim of this trial is to compare the effect of acetated ringer's solution with&#xD;
      that of saline for therapy on the incidence and development of major adverse renal events&#xD;
      among septic shock patients. The investigators hypothesize that use of acetated ringer's&#xD;
      solution for resuscitation among septic shock patients will reduce the incidence of major&#xD;
      adverse kidney events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in&#xD;
      early septic shock. However, evidence have associated saline with hyperchloremia and&#xD;
      secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney&#xD;
      injury (AKI) and mortality. The primary aim of this trial is to compare the effect of&#xD;
      acetated ringer's solution with that of saline for therapy on the incidence and development&#xD;
      of major adverse renal events among septic shock patients. The investigators hypothesize that&#xD;
      use of acetated ringer's solution for resuscitation among septic shock patients will reduce&#xD;
      the incidence of major adverse kidney events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Cluster-randomized, multiple-center trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of major adverse renal events in 28 days</measure>
    <time_frame>28 day</time_frame>
    <description>Incidence of major adverse renal events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of kidney injury</measure>
    <time_frame>28 day</time_frame>
    <description>Incidence of kidney injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine（umol/L）</measure>
    <time_frame>28 day</time_frame>
    <description>serum creatinine（umol/L）</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Septic Shock Hyperdynamic</condition>
  <arm_group>
    <arm_group_label>saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Use saline for fluid resuscitation during the first 72 hours after enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetated Ringer's solution group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluid resuscitation</intervention_name>
    <description>Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment</description>
    <arm_group_label>Acetated Ringer's solution group</arm_group_label>
    <arm_group_label>saline group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy;&#xD;
&#xD;
          2. Likely requirement for immediate hemodialysis or renal replacement therapy;&#xD;
&#xD;
          3. Patients have already received fluids for more than 4 liters;&#xD;
&#xD;
          4. Patient in extremis or death deemed imminent and inevitable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.</citation>
    <PMID>24638143</PMID>
  </results_reference>
  <results_reference>
    <citation>Peters E, Antonelli M, Wittebole X, Nanchal R, Francois B, Sakr Y, Vincent JL, Pickkers P. A worldwide multicentre evaluation of the influence of deterioration or improvement of acute kidney injury on clinical outcome in critically ill patients with and without sepsis at ICU admission: results from The Intensive Care Over Nations audit. Crit Care. 2018 Aug 3;22(1):188. doi: 10.1186/s13054-018-2112-z.</citation>
    <PMID>30075798</PMID>
  </results_reference>
  <results_reference>
    <citation>Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.</citation>
    <PMID>21705897</PMID>
  </results_reference>
  <results_reference>
    <citation>Suetrong B, Pisitsak C, Boyd JH, Russell JA, Walley KR. Hyperchloremia and moderate increase in serum chloride are associated with acute kidney injury in severe sepsis and septic shock patients. Crit Care. 2016 Oct 6;20(1):315. doi: 10.1186/s13054-016-1499-7.</citation>
    <PMID>27716310</PMID>
  </results_reference>
  <results_reference>
    <citation>Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.</citation>
    <PMID>24674927</PMID>
  </results_reference>
  <results_reference>
    <citation>Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.</citation>
    <PMID>23073953</PMID>
  </results_reference>
  <results_reference>
    <citation>Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.</citation>
    <PMID>29485925</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>Zhongda Hospital,Southeast University, China</investigator_title>
  </responsible_party>
  <keyword>Crystalloid</keyword>
  <keyword>Renal failure</keyword>
  <keyword>Renal dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</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/NCT04507672
org study id: 2018ZDSYLL105-P01
nct id: NCT04507672
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this trial is to compare the effect of acetated ringer's solution with
      that of saline for therapy on the incidence and development of major adverse renal events
      among septic shock patients. The investigators hypothesize that use of acetated ringer's
      solution for resuscitation among septic shock patients will reduce the incidence of major
      adverse kidney events.
Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in
      early septic shock. However, evidence have associated saline with hyperchloremia and
      secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney
      injury (AKI) and mortality. The primary aim of this trial is to compare the effect of
      acetated ringer's solution with that of saline for therapy on the incidence and development
      of major adverse renal events among septic shock patients. The investigators hypothesize that
      use of acetated ringer's solution for resuscitation among septic shock patients will reduce
      the incidence of major adverse kidney events.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cluster-randomized, multiple-center trial
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of major adverse renal events in 28 days
time frame: 28 day
description: Incidence of major adverse renal events
measure: Incidence of kidney injury
time frame: 28 day
description: Incidence of kidney injury
measure: Serum creatinine（umol/L）
time frame: 28 day
description: serum creatinine（umol/L）
arm group label: saline group
arm group type: Placebo Comparator
description: Use saline for fluid resuscitation during the first 72 hours after enrollment
arm group label: Acetated Ringer's solution group
arm group type: Experimental
description: Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment
intervention type: Drug
intervention name: Fluid resuscitation
description: Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment
arm group label: Acetated Ringer's solution group
arm group label: saline group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
citation: Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
PMID: 24638143
citation: Peters E, Antonelli M, Wittebole X, Nanchal R, Francois B, Sakr Y, Vincent JL, Pickkers P. A worldwide multicentre evaluation of the influence of deterioration or improvement of acute kidney injury on clinical outcome in critically ill patients with and without sepsis at ICU admission: results from The Intensive Care Over Nations audit. Crit Care. 2018 Aug 3;22(1):188. doi: 10.1186/s13054-018-2112-z.
PMID: 30075798
citation: Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
PMID: 21705897
citation: Suetrong B, Pisitsak C, Boyd JH, Russell JA, Walley KR. Hyperchloremia and moderate increase in serum chloride are associated with acute kidney injury in severe sepsis and septic shock patients. Crit Care. 2016 Oct 6;20(1):315. doi: 10.1186/s13054-016-1499-7.
PMID: 27716310
citation: Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
PMID: 24674927
citation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
PMID: 23073953
citation: Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
PMID: 29485925
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: Zhongda Hospital,Southeast University, China
mesh term: Shock, Septic
mesh term: Shock