Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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.

Publication citations

Additional files

Editorial Notes