CRT Hydration in the Last Days of Life (Feasibility Study)

Summary

It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.

The feasibility study will be done in twelve units (hospitals, hospices) in England \& Wales; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any symptoms.

Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the fluids given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.

Conditions

• Cancer

Interventions

OTHER

Non-Clinically Assisted Hydration arm

Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care

OTHER

Clinically Assisted Hydration arm

Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care, and clinically assisted hydration.

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust

  collaborator OTHER

• The Christie NHS Foundation Trust

  collaborator OTHER

• Leckhampton Hall Hospice (Cheltenham)

  collaborator UNKNOWN

• Pilgrims Hospices (Kent)

  collaborator UNKNOWN

• St Clare Hospice (Hastingwood)

  collaborator UNKNOWN

• New Cross Hospital, Wolverhampton

  collaborator UNKNOWN

• St Giles Hospice, Lichfield

  collaborator UNKNOWN

• St Mary;s Hospice, Birmingham

  collaborator UNKNOWN

• Velindre NHS Trust

  collaborator OTHER_GOV

• St Richards Hospice, Worcester

  collaborator UNKNOWN

• St Catherines Hospice, Crawley

  collaborator UNKNOWN

• St Margaret Hospice,Somerset

  collaborator UNKNOWN

• University of Surrey

  lead OTHER

Principal Investigators

• Andrew Davies · Royal Surrey County Hospital NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• United Kingdom

Study Locations