Hydration Amongst Nurses and Doctors Oncall (HANDsOn)

September 2, 2014 updated by: University of Nottingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Queens Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Nurses and doctors oncall working on acute medical and surgical admissions wards at the Queens Medical Centre Nottingham

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
medical staff
Nurses and doctors oncall

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
Participants will be followed up for the duration of their shift, approximately 12- 14 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of hydration status on cognitive function
Time Frame: Participants will be followed up for the duration of their shift, approximately 12- 14 hours.

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
Participants will be followed up for the duration of their shift, approximately 12- 14 hours.
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.
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.
Participants will be followed up for the duration of their shift, approximately 12- 14 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loughborough University
European Hydration Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dileep N Lobo, MBBS,DM,FRCS, University of Nottingham
  • Principal Investigator: Dileep N Lobo, MBBS,DM,FRCS, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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