Study into the control of blood pressure and antihypertensive medication withdrawal in haemodialysis patients by programmed reduction in dry weight

ISRCTN ISRCTN12355432
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

Derby Hospitals NHS Foundation Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesWhether 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) studiedCardiovascular: Hypertension
InterventionWe 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 typeOther
Primary outcome measurePrimary 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 measuresSecondary end points:
1. Correlation between satisfactory pre dialysis BP and 24 hour BP profile
2. Patient tolerability (symptoms)
Overall study start date01/04/2005
Completion date01/04/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteriaChronic haemodialysis patients
Key exclusion criteria1. 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 enrolment01/04/2005
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan