Hydration and Outcome in Older Patients | NCT01703715

Studies
Hydration and Outcome in Older Patients

NCT01703715

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Jul 15, 2014Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Dehydration

Interventions

The Hydrant

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

Jul 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

Aug 2012

Primary Completion Date

Apr 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 5, 2012

First Submission Date that Met QC Criteria

Oct 5, 2012

First Posted Date

Oct 10, 2012Estimated

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

Jul 14, 2014

Last Update Posted Date

Jul 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients aged 65 years and over		All patients aged 65 years and over admitted to acutely to medical wards	Device: The Hydrant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Hydrant	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Osmolality		At admission and 48hrs post admission to hospital

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All patients admitted acutely to medical wards who are aged 65 years and over.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dileep N Lobo, MD, 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

Not provided

Browse Branches

Not provided

Description

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.