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A clinical trial looking at maintaining hydration at the end of life

A cluster randomised trial of clinically-assisted hydration in patients in the last days of life - CHELsea II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65858561
Enrollment
1600
Registered
2021-09-14
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in the last week of life (cancer, non-malignant disease) Other

Interventions

Research sites will be randomised to either “standard intervention A” or “standard intervention B” (see below), and this will become the standard of care at the research site for the duration of this

Sponsors

University of Surrey
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Estimated prognosis of =1 week 3. Patient unable to maintain sufficient oral fluid intake (i.e. <1l/day).

Exclusion criteria

Exclusion criteria: 1. Patient is dehydrated (patient eligible for inclusion after correction of dehydration) 2. Patient has a relevant Advance Directive to Refuse Treatment (ADRT) 3. Clinical indication for CAH 4. Clinical contraindication to CAH 5. Contraindication to cannulation 6. Total parenteral nutrition/enteral feeding in situ 7. Patient has had delirium in last 24 h 8. Patient has had audible upper airway secretions in last 24 h 9. Patient likely to be transferred elsewhere for end-of-life care

Design outcomes

Primary

MeasureTime frame
Number of patients that develop delirium during the study. The Nursing Delirium Screening Scale (Nu-DESC) will be used to diagnose patients with delirium.

Secondary

MeasureTime frame
Measured throughout the study: 1. The proportion of patients that receive as-required and/or regular medication for delirium (data derived from drug chart). 2. Time to the first dose of medication for delirium (as-required or regular – data derived from drug chart). 3. Modified Richmond Agitation and Sedation Scale (m-RASS) scores during the study (mean score; proportion time with score 0; proportion time with score 0 to -2 – data derived from clinical observation document). 4. The proportion of patients with audible upper airway secretions (“death rattle” – data derived from clinical observation document). 5. The proportion of patients that receive as-required and/or regular medication for audible upper airway secretions (data derived from drug chart). 6. Time to the first dose of medication for audible upper airway secretions (as-required or regular – data derived from drug chart). 7. Proportion patients that experience pain, shortness of breath, and nausea and vomiting (and require medication for these symptoms – data derived from clinical observation document and drug chart). 8. Adverse effects of clinically-assisted hydration (data derived from clinical observation document). 9. Overall survival (data derived from clinical observation document). 10. Health economic analysis (data derived from clinical observation document and drug chart). 11. Carer feedback on end-of-life care and research participation.

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactAndrew;Andrew McClave;McClave

;

a.mcclave@surrey.ac.uk;chelseaii@surrey.ac.uk-;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026