<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/NCT01703715</url>
  </required_header>
  <id_info>
    <org_study_id>12029</org_study_id>
    <nct_id>NCT01703715</nct_id>
  </id_info>
  <brief_title>Hydration and Outcome in Older Patients</brief_title>
  <acronym>HOOP</acronym>
  <official_title>Hydration and Outcome in Older Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended&#xD;
      length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration.&#xD;
      One of the biggest problems for many people with regard to getting a drink is easy,&#xD;
      independent access - if they can't reach the jug/cup without a struggle then they often will&#xD;
      go thirsty and potentially become dehydrated.&#xD;
&#xD;
      The purpose of this study is to investigate the impact of dehydration on outcome in patients&#xD;
      65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour,&#xD;
      independently accessible fluids on reducing dehydration as well as improving patient&#xD;
      experience.&#xD;
&#xD;
      We hypothesise that patients who are dehydration will take longer to recover from illness and&#xD;
      stay in hospital for longer periods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 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>Serum Osmolality</measure>
    <time_frame>At admission and 48hrs post admission to hospital</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>Patients aged 65 years and over</arm_group_label>
    <description>All patients aged 65 years and over admitted to acutely to medical wards</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Hydrant</intervention_name>
    <description>The Hydrant is a new form of &quot;drinking system&quot; that may be used to provide continuous access to hydration will be given to 20 patients. 10 of the patients will have mild cognitive impairment with Mini Mental State Examination less than 24 and 10 with normal cognitive function. Patients and staff will be interviewed to assess the feasibility of the hydrant.</description>
    <arm_group_label>Patients aged 65 years and over</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Participants provide 5mls of whole blood on admission, at 48 hours post admission and at 3&#xD;
      month following discharge. This blood is to be analysed for urea, creatinine, sodium,&#xD;
      potassium, osmolality, full blood count as well as renin and aldosterone.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted acutely to medical wards who are aged 65 years and over.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. - All patients of 65 years and over that are admitted acutely to medical wards&#xD;
&#xD;
          2. - Ward staff who have been working in the clinical area for the duration of the trial&#xD;
             (The Hydrant part of the study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. - Patients who are moribund&#xD;
&#xD;
          2. - Patients who are doubly incontinent&#xD;
&#xD;
          3. - Patients on the end of life pathway&#xD;
&#xD;
          4. - Patients with terminal illness with a known life expectancy less than 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dileep N Lobo, MD, 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>July 2014</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hydration</keyword>
  <keyword>Elderly patients</keyword>
  <keyword>Age 65 years and over</keyword>
  <keyword>Admitted acutely to medical admissions ward</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/NCT01703715
org study id: 12029
nct id: NCT01703715
lead sponsor: 
has dmc: Yes
Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended
      length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration.
      One of the biggest problems for many people with regard to getting a drink is easy,
      independent access - if they can't reach the jug/cup without a struggle then they often will
      go thirsty and potentially become dehydrated.

      The purpose of this study is to investigate the impact of dehydration on outcome in patients
      65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour,
      independently accessible fluids on reducing dehydration as well as improving patient
      experience.

      We hypothesise that patients who are dehydration will take longer to recover from illness and
      stay in hospital for longer periods.
observational model: Cohort
time perspective: Prospective
measure: Serum Osmolality
time frame: At admission and 48hrs post admission to hospital
arm group label: Patients aged 65 years and over
description: All patients aged 65 years and over admitted to acutely to medical wards
intervention type: Device
intervention name: The Hydrant
description: The Hydrant is a new form of "drinking system" that may be used to provide continuous access to hydration will be given to 20 patients. 10 of the patients will have mild cognitive impairment with Mini Mental State Examination less than 24 and 10 with normal cognitive function. Patients and staff will be interviewed to assess the feasibility of the hydrant.
arm group label: Patients aged 65 years and over
Participants provide 5mls of whole blood on admission, at 48 hours post admission and at 3
      month following discharge. This blood is to be analysed for urea, creatinine, sodium,
      potassium, osmolality, full blood count as well as renin and aldosterone.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Dileep N Lobo, MD, FRCS
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dehydration