DehydrationHOOPNCT01703715
Hydration and Outcome in Older Patients
An observational study of Dehydration, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dehydration
- What is being tested?
- The Hydrant
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients admitted acutely to medical wards who are aged 65 years and over.
Who may be able to join
- - All patients of 65 years and over that are admitted acutely to medical wards
- - Ward staff who have been working in the clinical area for the duration of the trial (The Hydrant part of the study).
Who cannot join
- - Patients who are moribund
- - Patients who are doubly incontinent
- - Patients on the end of life pathway
- - Patients with terminal illness with a known life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
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.
- Conditions
- Dehydration
- Being tested
- The Hydrant
- Keywords
- Hydration, Elderly patients, Age 65 years and over, Admitted acutely to medical admissions ward
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The HydrantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 65 years and over | All patients aged 65 years and over admitted to acutely to medical wards Receives: Device: The Hydrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Osmolality
Measured: At admission and 48hrs post admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dileep N Lobo, MD, FRCS, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703715
- Sponsor's protocol ID
- 12029
- Acronym
- HOOP
- Status last verified
- Jul 2014
- First submitted
- 5 Oct 2012
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration and Outcome in Older Patients
- ClinicalTrials.gov ID
- NCT01703715
- Acronym / sponsor ID
- HOOP / 12029
- Conditions
- Dehydration
- Keywords
- Hydration, Elderly patients, Age 65 years and over, Admitted acutely to medical admissions ward
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 65 years and over | – | Device: The HydrantAll patients aged 65 years and over admitted to acutely to medical wards |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients admitted acutely to medical wards who are aged 65 years and over.
Key inclusion criteria (2 listed)
- - All patients of 65 years and over that are admitted acutely to medical wards
- - Ward staff who have been working in the clinical area for the duration of the trial (The Hydrant part of the study).
Key exclusion criteria (4 listed)
- - Patients who are moribund
- - Patients who are doubly incontinent
- - Patients on the end of life pathway
- - Patients with terminal illness with a known life expectancy less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The HydrantThe 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. | Device | Patients aged 65 years and over |
Primary outcome
Serum Osmolality
Time frame: At admission and 48hrs post admission to hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep N Lobo, MD, FRCS principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Osmolality (time frame: At admission and 48hrs post admission to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.