Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Target Weight Correction and Vascular Stiffness in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929471
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations

Applied medical device:

  1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload.
  2. Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention.

Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension.

Aim of the study:

  1. To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements.
  2. To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use.
  3. To show that this approach does not lead to more episodes with intradialytic hypotension.

The number of patients: 70 patients


Condition or disease Intervention/treatment Phase
Fluid Overload Vascular Stiffness Other: Target weight correction protocol Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Patients to be subjected to a fluid overload correction protocol.
Other: Target weight correction protocol
The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).

No Intervention: Control group
Patient will be followed but no fluid overload correction protocol will be applied.



Primary Outcome Measures :
  1. Fluid volume [ Time Frame: through the study completion, an average of 6 months ]
    Improvement in fluid status towards normovolemia (<1.1 L fluid overload)


Secondary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: Through the study completion, an average of 6 months ]
    Improvement in pulse wave velocity (millimetre/second)-one of vascular stiffness measurements

  2. Augmentation index [ Time Frame: Through the study completion, an average of 6 months ]
    Improvement in augmentation index (%)-one of vascular stiffness measurements

  3. Anti hypertensive medications use [ Time Frame: Through the study completion, an average of 6 months ]
    Reduction in the number of anti hypertensive medications use.


Other Outcome Measures:
  1. Intradialytic hypotensive episodes (IDH) [ Time Frame: Through the study completion, an average of 6 months ]
    The intervention will not lead to IDH episodes that happen during dialysis treatment. Such episodes including cramps, hypotension, and dizziness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years old) outpatients on 3-4 times per week HD sessions for at least 6 weeks with a life expectancy >6 months.
  • Fluid overload ≥1.1L.
  • Medically stable patient.
  • Minimum of 3 hours of dialysis per session.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Declined informed consent.

    • Patients with cognitive dysfunction.
    • Severe life-limiting Comorbidities (malignant tumour, tuberculosis,....)
    • Surgery within six weeks of the study.
    • Nocturnal dialysis patients.
    • Patients expected to receive a transplant or move to another center within the duration of the study.
    • Patients with arteriovenous fistula issues.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929471


Contacts
Layout table for location contacts
Contact: Branko Braam, MD PhD 780-492-1867 braam@ualberta.ca
Contact: Aya Lafta, MSc Cand 780-492-1867 lafta@ualberta.com

Locations
Layout table for location information
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Branko Braam, MD phD    (780) 492-1867    braam@ualberta.ca   
Contact: aya lafta, MSc Cand    (780) 492-1867    lafta@ualberta.ca   
Sub-Investigator: Aya Lafta, MSc Cand         
Sponsors and Collaborators
University of Alberta
Investigators
Layout table for investigator information
Principal Investigator: Branko Braam, MD PhD University of Alberta

Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03929471     History of Changes
Other Study ID Numbers: Pro00086730
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No