A Cluster Randomised Trial of Clinically Assisted Hydration in Patients in the Last Days of Life

Study ID: 53300
Short Title: CHElsea II Trial
Trust Name: HHFT,SFT,UHS
Recruitment Site: Andover War Memorial Hospital,Royal Hampshire County Hospital,Salisbury District Hospital,Southampton General Hospital,Weldmar Hospicecare Trust
Disease Area: SPCPS
Phase: N/A
Expected End Date: 01/09/2024
Postcode: RG24 9NA
SO22 5DG
Non-NHS Activity in Wessex
SP2 8BJ
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Estimated prognosis of death < = 1 week. [Clinical opinion - MDT]. Patient unable (or clinical opinion that they will soon be unable to) to maintain sufficient oral fluid intake (i.e., < 1L/day).

a) patient is dehydrated (patient eligible for inclusion after correction of dehydration) b) patient has a relevant Advance Directive to Refuse Treatment (ADRT) c) clinical indication for CAH d) clinical contraindication to CAH e) contraindication to cannulation f) total parenteral nutrition/enteral feeding in situ g) patient has had delirium in last 24 hours h) patient has had audible upper airway secretions in last 24 hours i) patient likely to be transferred elsewhere for end-of-life care j) patient has clinically significant cardiac failure as deemed by clinical team (see criteria ā€œdā€) k) patient has clinically significant renal failure as deemed by clinical team (see criteria ā€œdā€) l) patient has clinically significant dementia as deemed by clinical team (potential false positives on delirium screening)

Clinically assisted hydration at the end of life is much debated by healthcare professionals (HCP), it is also a debate that has moved into the public domain, which has caused much contention and anxiety for the dying patient, relatives and Health Care Professionals. The reason for the debate, contention and anxiety, is there is a lack of good quality research, which provides the evidence that guides end of life practice. The CHELsea II trial aims to provide robust data to enable new guidance on the use of assisted hydration in this patient group. The CHELsea II trial is a cluster randomised trial (sites randomised rather than participants) comparing the standard mouthcare with Clinically Assisted Hydration (CAH) versus the standard of mouthcare only in patients who are in the last days of life. Delirium can be one of the most distressing aspects of end of life and the CHELsea II trial will uniquely address the specific issue of the use of CAH at the end-of-life and to use an evidence based approach to create a pathway for the majority of end of life patients and to asses the reduction of delirium utilising CAH in this group of patients.

Study MapList of studies

Accessibility tools

Return to header