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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list