A major clinical trial investigating the role of clinically assisted hydration (CAH) in end-of-life care has launched across the United Kingdom, addressing one of medicine's most debated palliative care practices. The CHELsea II trial, coordinated by the Surrey Clinical Trials Unit, will evaluate whether providing assisted hydration benefits patients in their final days of life.
Study Design and Scope
The cluster randomized trial encompasses 80 research sites, including NHS hospitals and hospices across England, Wales, Scotland, and Northern Ireland. Each site will be randomly assigned to either provide or withhold CAH as their standard of care, with an anticipated enrollment of 1,600 participants over two years.
Participating centers must have specialist palliative care capabilities, with hospitals requiring either dedicated palliative care units or designated beds. The trial will include both cancer and non-malignant disease patients, expanding upon its predecessor feasibility study.
Protocol and Implementation
Patients receiving CAH will be administered dextrose saline (4% dextrose, 0.18% sodium chloride) at a volume of 25 mL/kg/day, delivered either intravenously or subcutaneously. The dosing aligns with National Institute for Health and Care Excellence (NICE) guidance, particularly considering the needs of elderly or frail patients.
"This represents the first large-scale attempt to definitively answer questions about hydration's role in end-of-life care," explains the research team. The study employs rigorous monitoring protocols, with participants assessed every four hours for:
- Delirium using the Nursing Delirium Screening Scale (Nu-DESC)
- Sedation levels
- Presence of respiratory secretions
- Pain and other symptoms
- Potential adverse effects
Primary Outcomes and Analysis
The trial's primary endpoint focuses on delirium prevalence, hypothesizing that maintained hydration may reduce confusion by preserving renal function and preventing toxin buildup. Researchers aim to demonstrate a clinically meaningful 10% reduction in delirium occurrence among the CAH group.
Secondary outcomes include:
- Prevalence of audible upper airway secretions
- Pain and symptom control
- Overall survival
- Treatment tolerability
- Health economic implications
Ethical Considerations and Patient Protection
The study incorporates comprehensive consent processes, acknowledging the unique challenges of research involving end-of-life patients. Multiple safeguards ensure ethical participation, including provisions for both personal and nominated consultees when patients lack capacity to consent.
The trial design reflects extensive consultation with patient and public involvement (PPI) groups, including input from Marie Curie Voices, ensuring the research addresses genuine clinical needs while maintaining patient dignity and comfort.
Clinical Implications
This research addresses a critical evidence gap in palliative medicine, where current hydration practices vary widely, with CAH usage ranging from 12% to 88% in cancer patients' final week of life. The results could significantly impact end-of-life care standards and provide much-needed clarity for clinical decision-making.
The study continues through September 2024, with results expected to influence future palliative care guidelines and standardize hydration protocols for end-of-life patients across healthcare settings.
