Condition category
Urological and Genital Diseases
Date applied
12/11/2008
Date assigned
23/12/2008
Last edited
23/12/2008
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 Jennifer MacRae

ORCID ID

Contact details

Foothills Medical Centre
C210
1403 29th Street NW
Calgary
T2N 2T9
Canada
+1 403 944 8168
jennifer.macrae@calgaryhealthregion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of pneumatic compression stockings on haemodynamic parameters in haemodialysis patients: a randomised crossover trial

Acronym

Study hypothesis

Primary hypothesis:
To determine the effect of pneumatic compression devices (PCDs), compared to standard of care, on central blood volume in both intradialytic hypotension (IDH) prone and non-IDH prone haemodialysis patients.

Secondary hypothesis:
To determine the effect of PCDs on the haemodynamic response during haemodialysis in both IDH-prone and non-IDH prone patients.

Ethics approval

The University of Calgary Office of Medical Bioethics approved on 2nd October 2008 (ref: ED-21937)

Study design

Randomised single centre active-controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

End-stage kidney disease on haemodialysis

Intervention

For sequence 1, the patient will undergo three HD sessions with PCDs, followed by three HD sessions without PCDs. For sequence 2, the patient will undergo three HD sessions without PCDs, followed by three sessions with PCDs. PCDs will be applied firmly around the calves prior to the initiation of HD with compressions intermittently applied at 40 mmHg throughout HD sessions. Frequencies of the compressions will be three cycles of compressions and decompressions per minute. Each cycle of compression and decompression will last approximately ten seconds. Lower extremities of all patients will be kept horizontal during the dialysis run.

The total duration of treatment is three consecutive HD sessions at 4 hours each; the follow up period is the same.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The change in central blood volume with and without PCDs in both IDH-prone patients and non-IDH prone patients. Central blood volume will be determined using ultrasound dilution technique as per standard procedures. Determined within the first 30 minutes of HD and again within the last 15 minutes of the HD session; this is done for each of the study HD sessions (three with treatment, three with control).

Secondary outcome measures

Determined within the first 30 minutes of HD and again at the last 15 minutes of HD for each of the study sessions:
1. Cardiac output
2. Mean arterial pressure
3. Bioimpedance derived extracellular fluid (ECF) and intracellular fluid (ICF) values

Overall trial start date

01/12/2008

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic stable HD patients who have been on HD at least three times per week for at least 3 months
2. Both males and females, aged 18 - 95 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

51

Participant exclusion criteria

1. Dialysing with a central venous catheter
2. Vascular access dysfunction
3. Lower extremity arterial ulcers, severe peripheral arterial disease, lower extremity amputations
4. Active medical issues
5. Unable to provide informed consent

Recruitment start date

01/12/2008

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Foothills Medical Centre
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

c/o Jennifer MacRae
Foothills Medical Centre
Calgary Health Region
C210 1403-29th Street NW
Calgary
T2N 2T9
Canada
+1 403 944 8168
jennifer.macrae@calgaryhealthregion.ca

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Calgary (Canada) - Faculty of Medicine, Division of Nephrology

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