CRT Hydration in the Last Days of Life (Feasibility Study)
- Conditions
- Cancer
- Interventions
- Other: Non-Clinically Assisted Hydration armOther: Clinically Assisted Hydration arm
- Registration Number
- NCT02344927
- Lead Sponsor
- University of Surrey
- Brief 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.
- Detailed Description
Background:
The provision of clinically-assisted hydration (CAH) at the end-of-life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include:
* the lack of evidence for / against CAH;
* the disparate opinions of healthcare professionals about CAH;
* the generally positive opinions of patients and their carers about CAH (and the generally negative opinions about withholding / withdrawing CAH).
It is, therefore, unsurprising that the provision of CAH at the end-of-life is extremely variable within clinical practice (i.e. 12-88% cancer patients in the last week of life).
Hypothesis:
CAH during the last days of life reduces the frequency of hyperactive delirium ("terminal agitation") in cancer patients as a result of maintenance of renal perfusion and the prevention of accumulation of toxins and drugs (i.e. prevention of dehydration).
Aims / objectives:
The aim of the definitive study is to evaluate the utility / role of CAH in cancer patients in the last days of life.
The aim of the feasibility study is to answer the question "can this study (the definitive study) be done".
The objectives of the feasibility study are to:
* assess the recruitment rate, i.e. number eligible patients, number recruited patients, barriers to recruitment;
* assess the retention rate;
* assess impact of trial procedures on clinical workload, i.e. completion of clinical assessment documentation, undertaking mouth care / CAH;
* assess the adequacy of resources to conduct the study at research centres;
* assess the adequacy of resources to support the study at Surrey Clinical Research Centre;
* determine other challenges for researchers / research centres;
* determine other challenges for Surrey Clinical Research Centre;
* assess safety of CAH
* determine total variability / intra-cluster correlation coefficient
Methodology:
The study is a cluster randomised trial with a mixed method of consenting. Consent sought from patients (whenever possible), or advice from a "personal consultee" (when a patient is unable to provide consent), or from a "nominated consultee" (when a patient is unable to provide consent, and there is no personal consultee).
Sites will be randomised to either "standard intervention arm A", or "standard intervention arm B". Patients in standard intervention arm A will be managed with continuance of oral intake (if appropriate), and regular "mouth care". Mouth care will be performed at least every four hours, and will correspond to the investigational site's policy / procedures for oral care in the terminal phase. Patients in standard intervention arm B will be managed with continuance of oral intake (if appropriate), regular "mouth care", and CAH, i.e. parenteral fluids. Again, mouth care will be performed at least every four hours, and will correspond to the investigational site's policy / procedures for oral care in the terminal phase. The parenteral fluids may be administered either intravenously or subcutaneously at the discretion of the medical and nursing team. The type of fluid to be administered will be dextrose saline (i.e. 4% dextrose, 0.18% sodium chloride), and the volume to be administered will be dependent on the patient's weight.
The primary endpoint of the definitive study is the frequency of hyperactive delirium ("terminal agitation"), and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions / "death rattle", dyspnoea, nausea and vomiting, adverse effects from the CAH, and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs, and other end-of-life medication.
A "cluster representation mechanism" (CRM) will be utilised, including the appointment of site-specific "study guardians" and "study gatekeepers", who will protect and respect the rights of the cluster and the individual participants within the cluster.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Clinically Assisted Hydration arm 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. Clinically Assisted Hydration arm 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
- Primary Outcome Measures
Name Time Method Recruitment rate Up to 12 months Sample size is 200
- Secondary Outcome Measures
Name Time Method Retention (% participants complete the study in a one year period) Up to 12 months \> 67% participants complete the study in a one year period
Adherence (% nursing observation completed in a one year period) Up to 12 months \>67% nursing observation completed in a one year period
Treatment related adverse events Up to 12 months \<50% participants have clinically assisted hydration discontinued due to treatment- related adverse events, in a one year period
Trial Locations
- Locations (12)
St Clare Hospice
🇬🇧Harlow, Essex, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, Midlands, United Kingdom
Pilgrims Hospice
🇬🇧Canterbury, Kent, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
🇬🇧Guildford, Surrey, United Kingdom
St Richards Hospice
🇬🇧Worcester, Worcestershire, United Kingdom
Leckampton Hall Hospice
🇬🇧Cheltenham, Gloucestershire, United Kingdom
St Giles Hospice
🇬🇧Lichfield, Staffordshire, United Kingdom
St Catherine's Hospice
🇬🇧Crawley, Sussex, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, Lancashire, United Kingdom
Velindre Cancer centre
🇬🇧Cardiff, United Kingdom
St Mary Hospice
🇬🇧Birmingham, West Midlands, United Kingdom
St Margaret's Hospice
🇬🇧Taunton, Somerset, United Kingdom