Study into the control of blood pressure and antihypertensive medication withdrawal in haemodialysis patients by programmed reduction in dry weight
ISRCTN | ISRCTN12355432 |
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DOI | https://doi.org/10.1186/ISRCTN12355432 |
Secondary identifying numbers | N0077114319 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 07/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chris W McIntyre
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Whether or not blood pressure can be controlled safely and effectively with a protocol driven program of dry weight reduction. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/04/2005 |
Completion date | 01/04/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 40 |
Key inclusion criteria | Chronic haemodialysis patients |
Key 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 |
Date of first enrolment | 01/04/2005 |
Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |