Does fluid administration in the terminally ill reduce the frequency and amount of sedation required for the management of agitation/restlessness?

ISRCTN	ISRCTN28898435
DOI	https://doi.org/10.1186/ISRCTN28898435
Protocol serial number	RRCC850F RATHBONE
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 16/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Joanne Rathbone
Scientific

23 Meath Way
Hunters Hill
Guisborough
Cleveland
TS14 7PG
United Kingdom

Phone	+44 (0)1287 295412

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/01/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key 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
Key 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
Date of first enrolment	10/01/2000
Date of final enrolment	10/01/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

23 Meath Way

Cleveland
TS14 7PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes