Is stepwise profiling of sodium and fluid removal during the dialysis of elderly patients clinically beneficial?

ISRCTN	ISRCTN34583783
DOI	https://doi.org/10.1186/ISRCTN34583783
Protocol serial number	RRCC164R XHN041
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 18/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicholas Hoenich
Scientific

4th Floor William Leach Building (M4,123)
Medical School
Framlington Place
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 6998
Email	nicholas.hoenich@ncl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The study propose to investigate strategies for improving haemodynamic stability during dialysis in elderly patients with a view to minimising hypotensive episodes. The study seeks to investigate the potential of controlling plasma volume during dialysis by variation of the rate of fluid removal and the rate of sodium (Na) influx from the dialysis fluid during treatment individually and in combination.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic renal failure; dialysis
Intervention	1. No intervention 2. Fluid removal profiling alone 3. Sodium profiling alone 4. Fluid and sodium profiling alone
Intervention type	Other
Primary outcome measure(s)	1. Number of nursing interventions 2. Changes in blood pressure 3. Episodes of hypotension (defined as a drop >30 mmHg systolic blood pressure) 4. At the end of each phase of the study (3 treatment sessions) patient quality of life will be assessed by the use of SF36 questionnaire, and a fatigue questionnaire as described by Prince MI. James OF. Holland NP. Jones DE. Validation of a fatigue impact score in primary biliary cirrhosis: towards a standard for clinical and trial use. Journal of Hepatology. 32(3):368-73, 2000
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/01/2001

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Key inclusion criteria	Study will be confined to patients with chronic renal failure on regular dialysis whose age is greater than 65 years
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	10/01/2000
Date of final enrolment	05/01/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

4th Floor William Leach Building (M4,123)

Newcastle upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2002		Yes	No