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
Protocol serial number	N0077114319
Sponsor	Department of Health
Funder	Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Secondary end points: 1. Correlation between satisfactory pre dialysis BP and 24 hour BP profile 2. Patient tolerability (symptoms)
Completion date	01/04/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan