Hydration Amongst Nurses and Doctors Oncall | NCT02230774

Studies
Hydration Amongst Nurses and Doctors Oncall

NCT02230774

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Sep 3, 2014Estimated

Enrollment

88Actual

Phase

Not provided

Conditions

Dehydration

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Sep 2, 2014

First Posted Date

Sep 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Name	Class
European Hydration Institute	OTHER
Loughborough University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

End points

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

88Actual

Label	Type	Description	Intervention Names
medical staff		Nurses and doctors oncall

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the prevalence of dehydration in nurses and doctors oncall.	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 Outcomes

Measure	Description	Time Frame
Impact of hydration status on cognitive function	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dileep N Lobo, MBBS,DM,FRCS	University of Nottingham	Study Chair
Dileep N Lobo, MBBS,DM,FRCS	University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queens Medical Centre		Nottingham	Nottinghamshire	NG7 2UH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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