Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Joanne Rathbone

ORCID ID

Contact details

23 Meath Way
Hunters Hill
Guisborough
Cleveland
TS14 7PG
United Kingdom
+44 (0)1287 295412

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC850F RATHBONE

Study information

Scientific title

Acronym

Study hypothesis

Aims:
1. Identify the frequency of agitation/restlessness for which a treatable cause cannot be found
2. Identify whether fluid status has any association with terminal agitation and restlessness
3. Identify whether the administration of fluid affects the amounts of sedation which need to be prescribed for the management of agitation/restlessness
4. Provide evidence for current clinical decision making and direction for future studies

Hypothesis:
There is no difference in the frequency or quality of agitation/restlessness in patients with a very short life expectancy whose oral fluid intake has fallen below 1000 ml/24 hours and are administered 1 litre of normal saline subcutaneously in 24 hours and those who are not.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Symptoms and general pathology

Intervention

Patients are randomised following consent to receive their 'normal' care plus 1 litre of normal saline subcutaneously or just their normal care. Fluids will be administered subcutaneously using a cannulae sited following an individual assessment of the patient. The fluid will be administered over 12 hours at a time which the patient finds most convenient.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A tool developed by Jones et al (1998) will be used in assessing the degree of agitation/restlessness which occurs. The data collection procedure will also include information on the degree of agitation, including any precipitating, aggravating or alleviating factors. Staff will therefore have to complete an assessment sheet which asks them to identify not only the frequency and degree of agitation but also a checklist of causative factors to exclude if the patient does become agitated. These will include assessment of pain, full bladder, constipation, anguish and the need for opioid rotation.
In general the assessor will be the qualified nurse on duty and the assessment should be performed once during each shift, on a morning between 5 am and 7 am, 10 am and 12 midday and on an evening between 5 pm and 7 pm. The end point of the study will be the death of the patient or discharge if they wish to die at home.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/2000

Overall trial end date

10/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who meet the inclusion criteria will be identified during the daily team meetings held within each of the hospices. The inclusion criteria are as follows:
1. Deemed to have a short life expectancy (Bozetti 1996)
2. Aged above 18
3. Inpatient within Butterick Hospice, Teesside Hospice, Hartlepool Hospice, St Oswalds Hospice or the Newcastle Marie Curie Centre
4. Oral intake has fallen below 1000 ml/24 hour and is recognised by the team as part of their deterioration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Known to have cerebral oedema
2. Known to have congestive cardiac failure
3. Known to have a coagulation disorder
4. Known to be in renal or liver failure or are hypercalcaemic
5. Known to have a tumour which has a direct influence on fluid balance

Recruitment start date

10/01/2000

Recruitment end date

10/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

23 Meath Way
Cleveland
TS14 7PG
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes