NCT01988181

Blood Volume Monitoring Guided Ultrafiltration Biofeedback on Reduction of Intra-dialytic Hypotensive Episodes in Hemodialysis: A Randomized Cross Over Study

Completed NA Last updated 24 July 2015

What this trial tests

NA trial testing BVM-UF biofeedback in Intradialytic Hypotension in 34 participants. Completed in 1 June 2015.

Timeline

1 June 2014

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	34
Start date	1 June 2014
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across Canada

Drugs / interventions tested

• BVM-UF biofeedback
• Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)

Conditions studied

• Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
• End Stage Renal Failure on Dialysis — all drugs for End Stage Renal Failure on Dialysis →

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Intradialytic Hypotension or End Stage Renal Failure on Dialysis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in the rate of symptomatic IDH during hemodialysis
  Time frame: During hemodialysis up to the 22 week study period
  The primary outcome will be rate of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of ≥20mm Hg when compared to baseline along with an abrupt onset headache, dizziness, unconsciousness, thirst, dyspnea, angina, muscle cramps, or vomiting (reflecting cerebral, cardiac, gastrointestinal, or musculoskeletal ischemia). The end of an episode of IDH will be defined as resolu

Sponsor's own description

As kidney function declines, the ability to maintain water balance is impaired and is most often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping, and chest pain. This sudden drop in blood pressure has been linked with complications of heart attacks, strokes and even death. Research has focused on different ways to prevent dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume monitoring biofeedback technology to monitor the patient's relative blood volume and automatically reduce the amount of fluid that is being removed when the blood volume is low to prevent the drop in blood pressure from occurring. This type of biofeedback device is currently available on some hemodialysis machines and while this approach appealing, it is not clear how effective this form of biofeedback is in preventing the drops in blood pressure.

We plan to determine if the use of biofeedback based on the changes in the patient's blood volume will reduce the number of sudden drops in blood pressure that occur during hemodialysis. To do this, we will compare patients treated with this technology to current hemodialysis practices and follow them for important adverse outcomes. The result of interest will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in blood pressure. We also plan to monitor the amount of water in the different body compartments, blood pressure, blood pressure medication use, markers of heart function, and patient symptoms and quality of life.

We hope that by providing information on this technology we can reduce the sudden drops in blood pressure in hemodialysis, the associated rates of serious disease or death, and improve patient quality of life.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Crossover Trial of Blood Volume Monitoring-Guided Ultrafiltration Biofeedback to Reduce Intradialytic Hypotensive Episodes with Hemodialysis.
   Leung KCW, Quinn RR, Ravani P, Duff H, et al · · 2017 · cited 48× · PMID 29018100 · DOI 10.2215/cjn.01030117
2. Ultrafiltration biofeedback guided by blood volume monitoring to reduce intradialytic hypotensive episodes in hemodialysis: study protocol for a randomized controlled trial.
   Leung KC, Quinn RR, Ravani P, MacRae JM. · · 2014 · cited 12× · PMID 25496294 · DOI 10.1186/1745-6215-15-483