<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/NCT03752450</url>
  </required_header>
  <id_info>
    <org_study_id>HYPNIC</org_study_id>
    <nct_id>NCT03752450</nct_id>
  </id_info>
  <brief_title>Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit</brief_title>
  <acronym>HYPNIC</acronym>
  <official_title>Insight in the Development and Recovery of Hypernatremia in Critically Ill Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</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>
      Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU)&#xD;
      and associated with increased mortality and length of stay. Previous studies focused on&#xD;
      predictors in the development and recovery of hypernatremia by including amount and types of&#xD;
      administered medication, fluid balance, laboratory results and changes in vital signs.&#xD;
      However, data of larger populations or data on infusion rates, fluid and salt balance or&#xD;
      renal replacement therapy is lacking. This study aims to provide better insight in the&#xD;
      development and recovery of hypernatremia through the collection of detailed information on&#xD;
      the input and output of fluids and salts in a larger group of patients than studied before.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU)&#xD;
      and associated with increased mortality and length of stay. The main mechanism is an&#xD;
      imbalance between sodium and total body water. Consequently, this poses multiple factors to&#xD;
      play a role in the development of hypernatremia. multifactorial. Previous studies focused on&#xD;
      predictors in the development of hypernatremia by including amount and types of administered&#xD;
      medication, fluid balance, laboratory results and changes in vital signs. However, data of&#xD;
      larger populations or data on infusion rates, fluid and salt balance or renal replacement&#xD;
      therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that&#xD;
      correction of hypernatremia can reduce the associated mortality risk.&#xD;
&#xD;
      This study aims to provide better insight in the development and recovery of hypernatremia&#xD;
      through the collection of detailed information on the input and output of fluids and salts in&#xD;
      a larger group of patients than studied before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2018</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of hypernatremia</measure>
    <time_frame>During ICU admission</time_frame>
    <description>Serum sodium levels &gt;145mmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery of hypernatremia</measure>
    <time_frame>During ICU admission</time_frame>
    <description>Serum sodium levels returning back to levels below 146mmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>During ICU admission as well as during hospital admission</time_frame>
    <description>Patient did or did not pass away.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Admission in ICU as well as in hospital</time_frame>
    <description>Number of days of admission</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Hypernatremia</condition>
  <arm_group>
    <arm_group_label>ICU patients</arm_group_label>
    <description>All patients admitted to ICU &gt;48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        As a cardiothoracic and oncologic center, the ICU in the Catharina Hospital mostly admits&#xD;
        postoperative patients. Other categories of admission are sepsis, respiratory&#xD;
        insufficiency, intoxication. However, all patients with an indication for hemodynamic,&#xD;
        respiratory of metabolic monitoring will be admitted. The Catharina Hospital is a tertiairy&#xD;
        referral hospital. The ICU has 32 beds.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt;17 years old&#xD;
&#xD;
          -  Admitted &gt;48 hours in ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Expected discharge same day as day of inclusion&#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>Eveline Mestrom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catharina Ziekenhuis Eindhoven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catharina Hospital Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.</citation>
    <PMID>23369520</PMID>
  </results_reference>
  <results_reference>
    <citation>Lindner G, Funk GC, Lassnigg A, Mouhieddine M, Ahmad SA, Schwarz C, Hiesmayr M. Intensive care-acquired hypernatremia after major cardiothoracic surgery is associated with increased mortality. Intensive Care Med. 2010 Oct;36(10):1718-1723. doi: 10.1007/s00134-010-1968-4. Epub 2010 Jul 24.</citation>
    <PMID>20658124</PMID>
  </results_reference>
  <results_reference>
    <citation>Marshall DC, Salciccioli JD, Goodson RJ, Pimentel MA, Sun KY, Celi LA, Shalhoub J. The association between sodium fluctuations and mortality in surgical patients requiring intensive care. J Crit Care. 2017 Aug;40:63-68. doi: 10.1016/j.jcrc.2017.02.012. Epub 2017 Feb 13.</citation>
    <PMID>28347943</PMID>
  </results_reference>
  <results_reference>
    <citation>Bihari S, Festa M, Peake SL, Seppelt IM, Williams P, Wilkins B, Bersten A. Sodium administration in critically ill paediatric patients in Australia and New Zealand: a multicentre point prevalence study. Crit Care Resusc. 2014 Jun;16(2):112-8.</citation>
    <PMID>24888281</PMID>
  </results_reference>
  <results_reference>
    <citation>Stelfox HT, Ahmed SB, Zygun D, Khandwala F, Laupland K. Characterization of intensive care unit acquired hyponatremia and hypernatremia following cardiac surgery. Can J Anaesth. 2010 Jul;57(7):650-8. doi: 10.1007/s12630-010-9309-1. Epub 2010 Apr 20.</citation>
    <PMID>20405264</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Eveline Mestrom</investigator_full_name>
    <investigator_title>Doctor of Medicine, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Water-electrolyte imbalance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypernatremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.</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/NCT03752450
org study id: HYPNIC
nct id: NCT03752450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU)
      and associated with increased mortality and length of stay. Previous studies focused on
      predictors in the development and recovery of hypernatremia by including amount and types of
      administered medication, fluid balance, laboratory results and changes in vital signs.
      However, data of larger populations or data on infusion rates, fluid and salt balance or
      renal replacement therapy is lacking. This study aims to provide better insight in the
      development and recovery of hypernatremia through the collection of detailed information on
      the input and output of fluids and salts in a larger group of patients than studied before.
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU)
      and associated with increased mortality and length of stay. The main mechanism is an
      imbalance between sodium and total body water. Consequently, this poses multiple factors to
      play a role in the development of hypernatremia. multifactorial. Previous studies focused on
      predictors in the development of hypernatremia by including amount and types of administered
      medication, fluid balance, laboratory results and changes in vital signs. However, data of
      larger populations or data on infusion rates, fluid and salt balance or renal replacement
      therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that
      correction of hypernatremia can reduce the associated mortality risk.

      This study aims to provide better insight in the development and recovery of hypernatremia
      through the collection of detailed information on the input and output of fluids and salts in
      a larger group of patients than studied before.
observational model: Cohort
time perspective: Prospective
measure: Development of hypernatremia
time frame: During ICU admission
description: Serum sodium levels >145mmol/L
measure: Recovery of hypernatremia
time frame: During ICU admission
description: Serum sodium levels returning back to levels below 146mmol/L
measure: Mortality
time frame: During ICU admission as well as during hospital admission
description: Patient did or did not pass away.
measure: Length of stay
time frame: Admission in ICU as well as in hospital
description: Number of days of admission
arm group label: ICU patients
description: All patients admitted to ICU >48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eveline Mestrom, MD
role: Principal Investigator
affiliation: Catharina Ziekenhuis Eindhoven
facility: 
country: Netherlands
citation: Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
PMID: 23369520
citation: Lindner G, Funk GC, Lassnigg A, Mouhieddine M, Ahmad SA, Schwarz C, Hiesmayr M. Intensive care-acquired hypernatremia after major cardiothoracic surgery is associated with increased mortality. Intensive Care Med. 2010 Oct;36(10):1718-1723. doi: 10.1007/s00134-010-1968-4. Epub 2010 Jul 24.
PMID: 20658124
citation: Marshall DC, Salciccioli JD, Goodson RJ, Pimentel MA, Sun KY, Celi LA, Shalhoub J. The association between sodium fluctuations and mortality in surgical patients requiring intensive care. J Crit Care. 2017 Aug;40:63-68. doi: 10.1016/j.jcrc.2017.02.012. Epub 2017 Feb 13.
PMID: 28347943
citation: Bihari S, Festa M, Peake SL, Seppelt IM, Williams P, Wilkins B, Bersten A. Sodium administration in critically ill paediatric patients in Australia and New Zealand: a multicentre point prevalence study. Crit Care Resusc. 2014 Jun;16(2):112-8.
PMID: 24888281
citation: Stelfox HT, Ahmed SB, Zygun D, Khandwala F, Laupland K. Characterization of intensive care unit acquired hyponatremia and hypernatremia following cardiac surgery. Can J Anaesth. 2010 Jul;57(7):650-8. doi: 10.1007/s12630-010-9309-1. Epub 2010 Apr 20.
PMID: 20405264
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Eveline Mestrom
investigator title: Doctor of Medicine, Principal Investigator
mesh term: Hypernatremia
sharing ipd: Undecided
ipd description: If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.