<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/NCT02230774</url>
  </required_header>
  <id_info>
    <org_study_id>12118</org_study_id>
    <nct_id>NCT02230774</nct_id>
  </id_info>
  <brief_title>Hydration Amongst Nurses and Doctors Oncall</brief_title>
  <acronym>HANDsOn</acronym>
  <official_title>Hydration Amongst Nurses and Doctors Oncall</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Hydration Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Loughborough University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess and compare the hydration status of medical and&#xD;
      nursing staff and to investigate the relationship between the hydration status, cognitive&#xD;
      function and serum cortisol (marker of stress).&#xD;
&#xD;
      We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the&#xD;
      end of their working day. Some, as in other occupations, may be dehydrated at the start of&#xD;
      their working day. This is likely to be associated with impairment in cognitive performance&#xD;
      at the end of the working day compared to the beginning and expected to be more pronounced&#xD;
      after a night shift. There may be less noticeable difference amongst nursing staff given the&#xD;
      protected break time. Dehydration and associated impairment in cognition is of important&#xD;
      clinical value as it can impact patient care. participants will be involved in the study for&#xD;
      two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15&#xD;
      medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day&#xD;
      and 15 night shifts from each group). Those that do not work both day and night shifts will&#xD;
      participate for only one shift and a new participant will be recruited until target number of&#xD;
      shifts is achieved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      End points&#xD;
&#xD;
        1. To assess the hydration status of hospital staff nurses and doctors oncall at work by&#xD;
           measuring the following:&#xD;
&#xD;
             1. Urine and serum osmolality&#xD;
&#xD;
             2. Urine mass produced during the shift&#xD;
&#xD;
             3. Kidney function (U &amp;Es)&#xD;
&#xD;
             4. Bioimpedance measures&#xD;
&#xD;
                2- To assess the effect of hydration on status of cognitive function and subjective&#xD;
                feelings.&#xD;
&#xD;
                3- To assess the association between hydration status on stress hormone (cortisol)&#xD;
                levels.&#xD;
&#xD;
                Inclusion criteria All medical and nursing staff working on acute medical and&#xD;
                surgical admissions at the Queens Medical Centre Nottingham.&#xD;
&#xD;
                Exclusion Criteria:&#xD;
&#xD;
                Pregnancy Pre-existing kidney disease Patients on diuretics Unwell in the past 6&#xD;
                week with acute illness that warrants hospital admission or prescribed medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Assess the prevalence of dehydration in nurses and doctors oncall.</measure>
    <time_frame>Participants will be followed up for the duration of their shift, approximately 12- 14 hours.</time_frame>
    <description>Using urine osmolality as a marker of hydration we aim to assess the prevalence of dehydration in health care professionals before and after day and night shifts. Comparing nurses and doctors oncall, day and night as well diffrence between those working in medical and surgical admissions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of hydration status on cognitive function</measure>
    <time_frame>Participants will be followed up for the duration of their shift, approximately 12- 14 hours.</time_frame>
    <description>We aim to assess the impact of hydration on key executive cognitive before and after day and night shifts, comparing day and night using the following tests:&#xD;
Visual search&#xD;
Stroop&#xD;
Sternberg&#xD;
Corsi</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The impact of hydration status on serum cortisol concentrations</measure>
    <time_frame>Participants will be followed up for the duration of their shift, approximately 12- 14 hours.</time_frame>
    <description>The impact of hydration status on serum cortisol concentrations as a surrogate marker of stress will be assessed before and after day and night shifts. with day and night shifts assessed separately given the diurnal variations in cortisol.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>medical staff</arm_group_label>
    <description>Nurses and doctors oncall</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and urine sampling&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Nurses and doctors oncall working on acute medical and surgical admissions wards at the&#xD;
        Queens Medical Centre Nottingham&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All medical and nursing staff working on acute medical and surgical admissions at the&#xD;
             Queens Medical Centre Nottingham&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy Pre-existing kidney disease Patients on diuretics Unwell in the past 6 week&#xD;
             with acute illness that warrants hospital admission or prescribed medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dileep N Lobo, MBBS,DM,FRCS</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dileep N Lobo, MBBS,DM,FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queens Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hydration</keyword>
  <keyword>cognitive function</keyword>
  <keyword>doctors</keyword>
  <keyword>nurses</keyword>
  <keyword>Nurses and Doctors oncall</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</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/NCT02230774
org study id: 12118
nct id: NCT02230774
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The main purpose of this study is to assess and compare the hydration status of medical and
      nursing staff and to investigate the relationship between the hydration status, cognitive
      function and serum cortisol (marker of stress).

      We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the
      end of their working day. Some, as in other occupations, may be dehydrated at the start of
      their working day. This is likely to be associated with impairment in cognitive performance
      at the end of the working day compared to the beginning and expected to be more pronounced
      after a night shift. There may be less noticeable difference amongst nursing staff given the
      protected break time. Dehydration and associated impairment in cognition is of important
      clinical value as it can impact patient care. participants will be involved in the study for
      two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15
      medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day
      and 15 night shifts from each group). Those that do not work both day and night shifts will
      participate for only one shift and a new participant will be recruited until target number of
      shifts is achieved.
End points

        1. To assess the hydration status of hospital staff nurses and doctors oncall at work by
           measuring the following:

             1. Urine and serum osmolality

             2. Urine mass produced during the shift

             3. Kidney function (U &Es)

             4. Bioimpedance measures

                2- To assess the effect of hydration on status of cognitive function and subjective
                feelings.

                3- To assess the association between hydration status on stress hormone (cortisol)
                levels.

                Inclusion criteria All medical and nursing staff working on acute medical and
                surgical admissions at the Queens Medical Centre Nottingham.

                Exclusion Criteria:

                Pregnancy Pre-existing kidney disease Patients on diuretics Unwell in the past 6
                week with acute illness that warrants hospital admission or prescribed medication.
observational model: Cohort
time perspective: Prospective
measure: Assess the prevalence of dehydration in nurses and doctors oncall.
time frame: Participants will be followed up for the duration of their shift, approximately 12- 14 hours.
description: Using urine osmolality as a marker of hydration we aim to assess the prevalence of dehydration in health care professionals before and after day and night shifts. Comparing nurses and doctors oncall, day and night as well diffrence between those working in medical and surgical admissions.
measure: Impact of hydration status on cognitive function
time frame: Participants will be followed up for the duration of their shift, approximately 12- 14 hours.
description: We aim to assess the impact of hydration on key executive cognitive before and after day and night shifts, comparing day and night using the following tests:
Visual search
Stroop
Sternberg
Corsi
measure: The impact of hydration status on serum cortisol concentrations
time frame: Participants will be followed up for the duration of their shift, approximately 12- 14 hours.
description: The impact of hydration status on serum cortisol concentrations as a surrogate marker of stress will be assessed before and after day and night shifts. with day and night shifts assessed separately given the diurnal variations in cortisol.
arm group label: medical staff
description: Nurses and doctors oncall
Serum and urine sampling
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dileep N Lobo, MBBS,DM,FRCS
role: Study Chair
affiliation: University of Nottingham
last name: Dileep N Lobo, MBBS,DM,FRCS
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dehydration