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 |
| Secondary identifying numbers | RRCC850F RATHBONE |
- 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
Scientific
23 Meath Way
Hunters Hill
Guisborough
Cleveland
TS14 7PG
United Kingdom
| Phone | +44 (0)1287 295412 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 10/01/2000 |
| Completion date | 10/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
23 Meath Way
Cleveland
TS14 7PG
United Kingdom
TS14 7PG
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
