Clinically assisted hydration may modestly increase the life span of terminally ill cancer patients, a new study concludes, but there is a controversy over whether or not this is beneficial for the patient.
The study is due to be published in Palliative Medicine.
The study, which was conducted in cancer patients in their last week of life who were unable to maintain sufficient oral fluid intake, compared usual care to assisted hydration. Fluids were given either intravenously or by subcutaneous injection. For patients who received assisted hydration, the survival rate was 26% higher than for patients who did not receive assisted hydration. This extrapolated to an average of an additional day and a half of life.
Because this was a feasibility study that investigated the routine use of clinically assisted hydration in cancer patients at the end of life, it was not powered to compare clinical outcomes between the two intervention arms.
But the results did confirm that appropriately designed randomized controlled trials can be conducted in this population and that a definitive study can be undertaken to evaluate the role that the provision of fluids plays in end-of-life care.
“The results of this study are certainly interesting, but a larger study is needed to confirm the role of clinically assisted hydration at the end of life,” commented author Andrew Davies, MD, a consultant in palliative medicine at Royal Surrey County Hospital, National Health Service Foundation Trust, United Kingdom, in a press statement.
He also pointed out that the results seen in this study, in which patients gained an extra day of life, can be both positive or negative, depending on the patient.
“For some patients and their families, living an extra day or so may be extremely important, as it can give them an opportunity to say their goodbyes, have family arrive from abroad, write a will, or even get married,” he said.
Living an extra day or so may be the worst thing possible.
“Nevertheless, for other patients, living an extra day or so may be the worst thing possible,” Dr Davies added.
No Consensus, Practice Varies
There is no consensus on fluid administration at the end of life, he noted. He added that the “provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine.”
Clinically assisted hydration at the end of life is one of the most contentious issues in medicine.
There are several reasons for this contention, note Dr Davies and his colleagues. These include a lack of evidence for or against clinically assisted hydration; disparate opinions of healthcare professionals and the generally positive opinions by patients and their caregivers about clinically assisted hydration; and the generally negative opinions about withholding or withdrawing clinically assisted hydration by patients and caregivers.
Given these factors, it is not surprising that use of clinically assisted hydration at the end of life varies widely in clinical practice, ranging from 12% to 88% of cancer patients, the authors note.
Feasibility Studied
To address some of these issues, the authors undertook a randomized controlled feasibility study to evaluate whether a definitive and adequately powered study can be conducted. The study utilized a novel cluster randomized design, as well as a novel consent process.
The authors point out that none of the randomized controlled trials that have been conducted to date have addressed the specific issue of using clinically assisted hydration routinely at the end of life and until death. In addition, in all of the previous studies, the cohorts included dehydrated patients who did not receive fluid in volumes sufficient to reverse dehydration.
The current study was conducted at 12 sites, or “clusters” (four cancer centers and eight hospices), and involved specialist palliative care teams and 200 terminally ill cancer patients in the last week of life who were unable to maintain sufficient oral fluid intake.
Participants were randomly assigned to either group A, which included patients who received regular mouth care and other forms of usual care, or to group B, in which patients received usual care plus clinically assisted hydration. Assessment was conducted every 4 hours, and data were collected on clinical problems, therapeutic interventions, and overall survival.
Among patients in group B, 28 (38.5%) discontinued hydration because of adverse effects. These included site problems (n = 2), localized edema (n = 13), generalized edema (n = 5), respiratory secretions (n = 6), and nausea and vomiting (n = 1). One patient’s reasons for discontinuance were not recorded. None of the adverse events were assessed as being severe, but a participant in the non–clinically assisted hydration group experienced a seizure that was evaluated as being life threatening.
Clinical outcomes were similar in both groups, but for patients receiving hydration, there was a nonsignificant delay in the need for “relevant as-required” medication as compared to those receiving standard care (65.06 vs 48.49 hours; P = .0989).
The incidence of audible upper airway secretions was similar in both cohorts, but there was a significant delay in the need to dispense medication for those receiving hydration (116.00 vs 57.82 hours; P < .001).
The results also suggested that although clinically assisted hydration did not appear to reduce the frequency of hyperactive delirium, it did appear to delay its onset, which is of importance in terms of quality of life (among patients with an m-RASS score ≥2, 13 [17.8%] patients in the intervention group received as-needed medication for agitation within 1 hour, compared with 21 [16.5%] patients in the usual-treatment group).
Studies need to be undertaken “so that we ensure that our practice is evidence-based, and that we provide the best possible end-of-life care to our patients and their carers,” the authors conclude. “Moreover, this study supports the use of cluster randomized trials in the palliative care/end-of-life care setting.”
Individual Approach
Approached for comment, Daniel Fischberg, MD, PhD, medical director, Pain and Palliative Care Department, the Queen’s Medical Center, Honolulu, Hawaii, agreed that this is an important topic to study.
“We need to treat patients individually, and fluids might worsen their symptoms or it might improve them,” Dr Fischberg told Medscape Medical News.
Sometimes families misinterpret the purpose of administering fluids, and this can be an emotional issue. “Often one of the first and most obvious signs that a patient is dying is that they stop eating,” he said. “That can be very distressing for everyone, and caregivers may feel that ‘if only we can get some food or fluid into them, they’ll be okay,’ but that isn’t going to happen.”
Thus, giving fluids can be mistakenly interpreted, but it is not going to stop the patient from dying, he pointed out. “It might make a difference in quality of life, or it could prolong dying.”
Historically, there has been a bias against administering clinically assisted hydration in hospice care, although Dr Fischberg points out that some patients do receive them in hospice. “But early in the hospice movement, they wanted to move away from invasive procedures, and there was concern that the patient could be getting too much fluid and this could cause respiratory symptoms.”
He emphasized that a good palliative team needs to be on board to determine the best route of care. “There are not a lot of data on this issue, and it is understudied, so it will be important to have good evidence from well-designed randomized clinical trials.”
The study was funded by the Research for Patient Benefit program of the National Institute of Health Research in the United Kingdom. The authors have disclosed no relevant financial relationships.
Palliat Med.
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