Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077114319
Study information
Scientific title
Acronym
Study hypothesis
Whether or not blood pressure can be controlled safely and effectively with a protocol driven program of dry weight reduction.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Hypertension
Intervention
We propose to study 40 patients currently undergoing chronic haemodialysis in a randomised un-blinded prospective fashion.
The first group will have their dry weight adjusted according to need as assessed at every dialysis session by nursing staff, and at monthly consultant review.
The second group will undergo a protocol driven program of dry weight reduction and antihypertensive withdrawal using the dialysis methods outlined above.
The two groups will be assessed for the effectiveness of BP reduction, ultimate reduction in dry weight, inter-dialytic weight gains, adequacy of delivered dialysis, antihypertensive use and frequency and severity of hypotensive (symptomatic or otherwise) events.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Primary end points:
1. The number of patients attaining pre-dialysis BP < 140/90 with partial or total withdrawal of antihypertensive medication.
2. Incidence of hypotensive episodes
Secondary outcome measures
Secondary end points:
1. Correlation between satisfactory pre dialysis BP and 24 hour BP profile
2. Patient tolerability (symptoms)
Overall trial start date
01/04/2005
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Chronic haemodialysis patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Clinical Evidence of fluid overload (peripheral or pulmonary oedema)
2. History of major cardiovascular event within the last year (myocardial infarction, CVA and major peripheral vascular disease episodes)
3. Patients having either acetate free biofiltration or haemodiafiltration
4. History of interdialytic weight gains of greater than 4 kg
5. Haemoglobin (Hb) less than 8 g/dl
6. Autonomic neuropathy
Recruitment start date
01/04/2005
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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