NCT01916668

Brief Summary

Observational evidence indicates that intradialytic hypertension is associated with high morbidity \& mortality. The investigators impression is that this problem may be more prevalent than initially suspected. To the investigators knowledge, there are no studies on intradialytic hypertension in the South African haemodialysis population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

February 1, 2013

Last Update Submit

May 6, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of intradialytic hypertension at four haemodialysis units in the Western Cape

    Up to 1 year

Secondary Outcomes (1)

  • Participants pre- and post hemodialysis bioimpedance measurements

    Up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic haemodialysis patients

You may qualify if:

  • Males and females age \> 18 years
  • Ability to give informed consent

You may not qualify if:

  • Inability to take blood pressure by routine methods in the upper limbs
  • Inability to give informed consent
  • Contraindications to bioimpedance monitoring (pre-existing implanted cardiac devices such as pacemakers, cardioverter defibrillators; amputees)
  • Intercurrent acute illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tygerberg Academic Hospital

Cape Town, Western Cape, 7505, South Africa

Location

Study Officials

  • Mogamat-Yazied Dr Chothia, FCP(SA)

    University of Stellenbosch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Nephrologist

Study Record Dates

First Submitted

February 1, 2013

First Posted

August 5, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations