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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28898435
Enrollment
Unknown
Registered
2004-01-23
Start date
2000-01-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptoms and general pathology Signs and Symptoms

Interventions

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 cann

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026