1. Why has this trial come about?
The stimulus for doing the trial is the recent withdrawal of the Liverpool Care Pathway, which was criticised for appearing to discourage the use of clinically-assisted hydration (fluid via a “drip”) in patients dying in hospital.
We want to determine whether or not clinically-assisted hydration improves the symptoms / experience of cancer patients in the last days of life.
2. How long has clinically-assisted hydration been given and why is this only just coming up for trials?
Clinically-assisted hydration has been used for a very long time in hospitals, and although some trials have been undertaken, none of these trials were rigorously performed (and so we still do not know whether or not clinically-assisted hydration improves the symptoms / experience of patients in the last days of life).
3. What are the benefits of clinically-assisted hydration? How long has it been used and what evidence supports its use?
Clinically-assisted hydration should prevent the development of dehydration, which might improve the symptoms / experience of patients in the last days of life. Nevertheless, at the moment, there is little evidence to support the use of clinically-assisted hydration in patients in the last few days of life.
4. Is this trial ethical?
The trial has been approved by the London-Bromley National Research Ethics Service (NRES) Committee (reference 14/LO/1543), and also the University of Surrey Research Ethics Committee.
5. What ethical questions does this trial raise?
The main ethical issue involves conducting a trial in a vulnerable group of patients – we have ensured that all treatment decisions are made by the clinical team looking after the patient (and not the research team), and that all patients receive a standard treatment for managing reduced fluid intake.
6. Isn't this too high a risk to be making in such a, literally, life-or-death situation?
In the United Kingdom, most patients do not receive clinically-assisted hydration in the last few days of life, and currently there is no evidence that withholding clinically-assisted hydration has a negative effect on prognosis (i.e. “speeds up” dying).
7. When will the trial start?
The trial will start in the Spring of 2015.
8. How will you monitor that the use of clinically-assisted hydration is working or not?
Patients in the trial will be constantly monitored by their clinical team, who will decide on clinical grounds whether to continue / discontinue the clinically-assisted hydration
9. What will be the system to opt out of the trial?
Patients can refuse to take part in the trial, and can withdraw at any time (without it affecting their end-of-life care).
10. How will consent be obtained?
Written consent must be obtained before a patient is entered into the trial: we are seeking consent for the use of the patient’s data, and not consent for giving clinically-assisted hydration or the other form of hydration (i.e. drinking, mouth care).
If the patient is able / competent, then they will be asked to sign a consent form to take part in the trial; if the patient is unable / incompetent, then a relative will be asked whether they think the patient would have given consent to take part in the trial.
Queries about this study should be directed to:
Peter La <firstname.lastname@example.org>