Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2014
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 Chris W McIntyre

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes