Contact information
Type
Scientific
Primary contact
Dr Nicholas Hoenich
ORCID ID
Contact details
4th Floor William Leach Building (M4,123)
Medical School
Framlington Place
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 6998
nicholas.hoenich@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC164R XHN041
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/01/2000
Overall trial end date
05/01/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Study will be confined to patients with chronic renal failure on regular dialysis whose age is greater than 65 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
10/01/2000
Recruitment end date
05/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
4th Floor William Leach Building (M4,123)
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2002 results in Chambers G, Hoenich NA. Is stepwise profiling of ultrafiltration and sodium beneficial to the elderly patient receiving haemodialysis therapy?. Journal of the American Society of Nephrology 2002, 13(supplement), 580A.