CHELsea II
Summary
CHELsea II
A CLUSTER RANDOMISED TRIAL OF CLINICALLY-ASSISTED HYDRATION IN PATIENTS IN THE LAST DAYS OF LIFE
This study follows on from a previous feasibility study. Several hospices across Luton, Essex and Herts Valley are taking part, for more information about the study please see the link below.
For more information please click HERE for the published feasibility study.
Sponsor -Surrey Clinical Trials Unit, University of Surrey
Trial End Date -01/09/2024
Type of Study -Recruiting-
Hospice Involvement
Identify suitable participants
Eligibility and consent checks
Complete clinical research forms and enter into electronic system
report AE/SAE and protocol deviations
deliver intervention based on cluster randomisation.
Eligibility Criteria
Inclusion
a) any sex
b) age ≥ 18 years
c) estimated prognosis of ≤ 1 week. [Clinical opinion - MDT].
d) patient unable to maintain sufficient oral fluid intake (i.e., < 1L/day).
Exclusion
a) patient is dehydrated (guidance on indictors of dehydration in Appendix 5)
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 “d”)
ISRCTN - 65858561
Version 1 27 Jul 2022 Page 18 of 56
k) patient has clinically significant renal failure as deemed by clinical team (see criteria “d”)
l) patient has clinically significant dementia as deemed by clinical team (potential false positives on delirium screening)
***We are not seeking any further EOI's for this study, demonstrating some of the studies outside of GP practices that we are running in LEH***