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

This study has been completed.
Sponsor:
Collaborators:
Royal Surrey County Hospital
The Christie NHS Foundation Trust
Leckhampton Hall Hospice (Cheltenham)
Pilgrims Hospices (Kent)
St Clare Hospice (Hastingwood)
New Cross Hospital, Wolverhampton
St Giles Hospice, Lichfield
St Mary;s Hospice, Birmingham
Velindre NHS Trust
St Richards Hospice, Worcester
St Catherines Hospice, Crawley
St Margaret Hospice,Somerset
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT02344927
First received: June 4, 2014
Last updated: March 14, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Cancer
Other: Non-Clinically Assisted Hydration arm
Other: Clinically Assisted Hydration arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Cluster Randomised Trial of Alternative Forms of Hydration in Cancer Patients in the Last Days of Life (Feasibility Study)

Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Recruitment rate [ Time Frame: Up to 12 months ]
    Sample size is 200


Secondary Outcome Measures:
  • Retention (% participants complete the study in a one year period) [ Time Frame: Up to 12 months ]
    > 67% participants complete the study in a one year period

  • Adherence (% nursing observation completed in a one year period) [ Time Frame: Up to 12 months ]
    >67% nursing observation completed in a one year period

  • Treatment related adverse events [ Time Frame: Up to 12 months ]
    <50% participants have clinically assisted hydration discontinued due to treatment- related adverse events, in a one year period


Enrollment: 200
Study Start Date: February 2015
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-Clinically Assisted Hydration arm

The interventions utilised within this trial are representative of standard clinical practice

  • Continuance of oral intake (if appropriate)
  • Regular (4 hourly) mouth care
  • Standard management of pain and other symptoms in the terminal phase.
Other: Non-Clinically Assisted Hydration arm
Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care
Active Comparator: Clinically Assisted Hydration arm

The interventions utilised within this trial are representative of standard clinical practice

  • Continuance of oral intake (if appropriate)
  • Regular (4 hourly) mouth care
  • Clinically-assisted hydration
  • Standard management of pain and other symptoms in the terminal phase
Other: Clinically Assisted Hydration arm
Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care, and clinically assisted hydration.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of cancer
  • Age ≥ 18 yr
  • Estimated prognosis of ≤ 1 week
  • Patient unable to maintain sufficient oral intake (1L / day)

Exclusion criteria:

  • Patient clinically dehydrated
  • Patient has hyperactive delirium ("terminal agitation") at present
  • Patient has had hyperactive delirium ("terminal agitation") in the last 24hr
  • Clinical indication for clinically-assisted hydration (e.g. hypercalcaemia)
  • Clinical contra-indication to clinically-assisted hydration (e.g. cardiac failure)
  • Clinical contra-indication to peripheral cannulation
  • Intravenous fluids / subcutaneous fluids / total parenteral nutrition (TPN) / enteral feeding or fluids already being administered
  • Patient likely to be transferred to another setting for end of life care (e.g. home, hospice)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02344927

Locations
United Kingdom
St Clare Hospice
Harlow, Essex, United Kingdom, CM179JX
Leckampton Hall Hospice
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
Pilgrims Hospice
Canterbury, Kent, United Kingdom, CT2 8JA
The Christie NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M20 4BX
New Cross Hospital
Wolverhampton, Midlands, United Kingdom, WV10 0QP
St Margaret's Hospice
Taunton, Somerset, United Kingdom, TA1 5HA
St Giles Hospice
Lichfield, Staffordshire, United Kingdom, WS14 9LH
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX
St Catherine's Hospice
Crawley, Sussex, United Kingdom, RH10 6BH
St Mary Hospice
Birmingham, West Midlands, United Kingdom, B29 7DA
St Richards Hospice
Worcester, Worcestershire, United Kingdom, WR5 2QT
Velindre Cancer centre
Cardiff, United Kingdom, CF14 2TL
Sponsors and Collaborators
University of Surrey
Royal Surrey County Hospital
The Christie NHS Foundation Trust
Leckhampton Hall Hospice (Cheltenham)
Pilgrims Hospices (Kent)
St Clare Hospice (Hastingwood)
New Cross Hospital, Wolverhampton
St Giles Hospice, Lichfield
St Mary;s Hospice, Birmingham
Velindre NHS Trust
St Richards Hospice, Worcester
St Catherines Hospice, Crawley
St Margaret Hospice,Somerset
Investigators
Principal Investigator: Andrew Davies Royal Surrey County Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT02344927     History of Changes
Other Study ID Numbers: CRC 340
Study First Received: June 4, 2014
Last Updated: March 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Surrey:
Cancer
End-of-life care
Clinically-assisted hydration

ClinicalTrials.gov processed this record on April 21, 2017