<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/NCT03840629</url>
  </required_header>
  <id_info>
    <org_study_id>DSRB2013/01040</org_study_id>
    <nct_id>NCT03840629</nct_id>
  </id_info>
  <brief_title>Fluid Tonicity and Hyponatraemia Post Surgery</brief_title>
  <official_title>Impact of Maintenance Fluid Tonicity on Natraemia in Post-surgical Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</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>
      Retrospective audit of adult patients who underwent major surgery in our institution, and&#xD;
      biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity&#xD;
      administered peri-operatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyponatraemia is a common electrolyte abnormality which is hospital-acquired in two-thirds of&#xD;
      cases, and can lead to obtundation, seizures, encephalopathy and death. In children, the use&#xD;
      of hypotonic maintenance fluids had been routine until recent evidence showing that they were&#xD;
      associated with an increased incidence of hyponatraemia, with consequent increases in&#xD;
      morbidity and mortality. Comparative data in adults is limited.&#xD;
&#xD;
      In our institution, the National University Hospital, Singapore, a hypotonic solution of&#xD;
      0.33% saline pre-mixed with 10mM KCl per 500ml has been in common use for years for surgical&#xD;
      patients. This is largely based on calculations of daily requirements (1-1.5mM/kg of sodium&#xD;
      and 1mM/kg of potassium) and reduction of risk associated with measuring out KCl and&#xD;
      injecting it into drip bags. However, this solution is hypotonic (134mM) compared to plasma,&#xD;
      and its administration could theoretically increase the risk of subsequent hyponatraemia.&#xD;
&#xD;
      In this single-centre retrospective observational study, we aim to compare the biochemical&#xD;
      outcomes of hospitalised surgical adult patients who have been given hypotonic (0.33% saline)&#xD;
      compared to isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution) between&#xD;
      March and September 2013. We hypothesize that hypotonic solutions are more likely to cause a&#xD;
      post-operative hyponatraemia and subsequent complications compared to their isotonic&#xD;
      counterparts. The complications of hyponatraemia are defined in this study as new ICU&#xD;
      admissions and increased mortality.&#xD;
&#xD;
      Inappropriate fluid prescription is a contributor to iatrogenic morbidity and mortality. Our&#xD;
      study aims to evaluate the safety of a hypotonic solution in standard use. The results will&#xD;
      help guide fluid choice, especially in the absence of current evidence-based national&#xD;
      guidelines. As it is a retrospective study, there are no risks involved.&#xD;
&#xD;
      This is a single-centre retrospective observational study based on electronic medical records&#xD;
      collected between the months of March 2012 and September 2013. Patients will be divided into&#xD;
      two groups - one which received hypotonic 0.33% saline, and another which received isotonic&#xD;
      or near-isotonic solutions (0.9% saline or Hartmann's solution). Serum sodium, chloride,&#xD;
      bicarbonate and creatinine measured pre-operatively will be compared to post-operative values&#xD;
      obtained 24-48 hours later.&#xD;
&#xD;
        1. All medication (including fluids) administered during an inpatient stay at NUH are&#xD;
           logged and stored electronically via the inpatient medication record system. Following a&#xD;
           patient's discharge, this information is stored on the hospital's servers and accessible&#xD;
           by pharmacy. By searching for a certain medication, e.g. &quot;normal saline&quot;, a list of all&#xD;
           patients given that medication during a certain time period can be generated, along with&#xD;
           associated data such as when the medication was commenced and stopped.&#xD;
&#xD;
        2. From this list of patients, their IDs can be used to extract surgical data from&#xD;
           electronic records which are automatically created every time an operative report (i.e.&#xD;
           every time a surgical procedure is completed) is issued. Variables obtained from this&#xD;
           database include the surgical procedure name, code, performing department, etc.&#xD;
&#xD;
        3. For biochemical data, the hospital's electronic medical records can be searched by&#xD;
           patient IDs. Details such as documented past medical history and laboratory indices are&#xD;
           available. By comparing dates of surgery to dates of renal panels taken for a specific&#xD;
           patient, pre-operative and post-operative variables can be identified and extracted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2014</start_date>
  <completion_date type="Actual">November 12, 2015</completion_date>
  <primary_completion_date type="Actual">June 12, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hyponatraemia</measure>
    <time_frame>48 to 72 hrs post surgery</time_frame>
    <description>Hyponatraemia post surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypokalemia</measure>
    <time_frame>48 to 72 hrs post surgery</time_frame>
    <description>Hypokalemia post surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>48 to 72 hrs post surgery</time_frame>
    <description>AKI post surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">659</enrollment>
  <condition>Hyponatremia</condition>
  <condition>Surgery</condition>
  <condition>Fluid and Electrolyte Imbalance</condition>
  <arm_group>
    <arm_group_label>Hypotonic fluid maintenance</arm_group_label>
    <description>exclusive administration of 0.33% saline mixed with potassium and dextrose 5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic fluid maintenance</arm_group_label>
    <description>exclusive administration of 0.9% saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No study intervention.</intervention_name>
    <arm_group_label>Hypotonic fluid maintenance</arm_group_label>
    <arm_group_label>Isotonic fluid maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult surgical patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  exclusive administration of either fluid types.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received saline boluses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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>Hyponatremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Request to be made to corresponding author please</ipd_description>
  </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/NCT03840629
org study id: DSRB2013/01040
nct id: NCT03840629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective audit of adult patients who underwent major surgery in our institution, and
      biochemical outcomes including hyponatremia, in relation to the maintenance fluid tonicity
      administered peri-operatively.
Hyponatraemia is a common electrolyte abnormality which is hospital-acquired in two-thirds of
      cases, and can lead to obtundation, seizures, encephalopathy and death. In children, the use
      of hypotonic maintenance fluids had been routine until recent evidence showing that they were
      associated with an increased incidence of hyponatraemia, with consequent increases in
      morbidity and mortality. Comparative data in adults is limited.

      In our institution, the National University Hospital, Singapore, a hypotonic solution of
      0.33% saline pre-mixed with 10mM KCl per 500ml has been in common use for years for surgical
      patients. This is largely based on calculations of daily requirements (1-1.5mM/kg of sodium
      and 1mM/kg of potassium) and reduction of risk associated with measuring out KCl and
      injecting it into drip bags. However, this solution is hypotonic (134mM) compared to plasma,
      and its administration could theoretically increase the risk of subsequent hyponatraemia.

      In this single-centre retrospective observational study, we aim to compare the biochemical
      outcomes of hospitalised surgical adult patients who have been given hypotonic (0.33% saline)
      compared to isotonic or near-isotonic solutions (0.9% saline or Hartmann's solution) between
      March and September 2013. We hypothesize that hypotonic solutions are more likely to cause a
      post-operative hyponatraemia and subsequent complications compared to their isotonic
      counterparts. The complications of hyponatraemia are defined in this study as new ICU
      admissions and increased mortality.

      Inappropriate fluid prescription is a contributor to iatrogenic morbidity and mortality. Our
      study aims to evaluate the safety of a hypotonic solution in standard use. The results will
      help guide fluid choice, especially in the absence of current evidence-based national
      guidelines. As it is a retrospective study, there are no risks involved.

      This is a single-centre retrospective observational study based on electronic medical records
      collected between the months of March 2012 and September 2013. Patients will be divided into
      two groups - one which received hypotonic 0.33% saline, and another which received isotonic
      or near-isotonic solutions (0.9% saline or Hartmann's solution). Serum sodium, chloride,
      bicarbonate and creatinine measured pre-operatively will be compared to post-operative values
      obtained 24-48 hours later.

        1. All medication (including fluids) administered during an inpatient stay at NUH are
           logged and stored electronically via the inpatient medication record system. Following a
           patient's discharge, this information is stored on the hospital's servers and accessible
           by pharmacy. By searching for a certain medication, e.g. "normal saline", a list of all
           patients given that medication during a certain time period can be generated, along with
           associated data such as when the medication was commenced and stopped.

        2. From this list of patients, their IDs can be used to extract surgical data from
           electronic records which are automatically created every time an operative report (i.e.
           every time a surgical procedure is completed) is issued. Variables obtained from this
           database include the surgical procedure name, code, performing department, etc.

        3. For biochemical data, the hospital's electronic medical records can be searched by
           patient IDs. Details such as documented past medical history and laboratory indices are
           available. By comparing dates of surgery to dates of renal panels taken for a specific
           patient, pre-operative and post-operative variables can be identified and extracted.
observational model: Cohort
time perspective: Retrospective
measure: Hyponatraemia
time frame: 48 to 72 hrs post surgery
description: Hyponatraemia post surgery
measure: Hypokalemia
time frame: 48 to 72 hrs post surgery
description: Hypokalemia post surgery
measure: Acute kidney injury
time frame: 48 to 72 hrs post surgery
description: AKI post surgery
arm group label: Hypotonic fluid maintenance
description: exclusive administration of 0.33% saline mixed with potassium and dextrose 5%
arm group label: Isotonic fluid maintenance
description: exclusive administration of 0.9% saline
intervention type: Other
intervention name: No study intervention.
arm group label: Hypotonic fluid maintenance
arm group label: Isotonic fluid maintenance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hyponatremia
sharing ipd: Undecided
ipd description: Request to be made to corresponding author please