The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension

June 10, 2019 updated by: Western Galilee Hospital-Nahariya

Rationale and objectives

  1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.
  2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intradialytic hypotension (IDH) or a significant fall in blood pressure (BP) is the most common complication that occurs during hemodialysis (HD) treatment, occurring in up to 20-33% of sessions.

Different mechanisms are involved in the pathogenesis of IDH including acute central hypovolemia, may be precipitated by rapid or excessive ultrafiltration that lead to intravascular volume depletion beyond the level of hemodynamic compensatory response. Other proposed mechanisms of intra vascular depletion are volume shift into the extra-vascular space due to rapid reduction in plasma osmolality, slow and incompatible vascular refilling rate and incorrectly low prescribed dry weight.

Autonomic dysfunction occurs in considerable amount of dialysis patients up to about 50% . This dysfunction reduces the ability to produce an adequate sympathetic response in the setting of acute volume diminution.

Due to the complexity of the dialysis treatment and absence of non- invasive technology, few studies followed the hemodynamic changes which occur during a dialysis session especially during IDH episodes.

OL- HDF is a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis.

Compared to conventional HD treatment, OL-HDF treatment was associated with lower incidence of IDH and better hemodynamic stability.

Bioelectrical impedance analysis is a method for estimating body composition in most of the cases. The Non-Invasive Cardiac System (NICaS) device (non-invasive cardiac system) applies the principle of Whole Body Bio-Impedance and provides continuous data regarding the hemodynamic status (i.e. heart rate, stroke volume, cardiac output, cardiac index, and total peripheral vascular resistance) as well as respiration rate and total body water.

Following the hemodynamic changes, the NICaS device will allow to shed light on the physiological mechanisms underlying the IDH phenomenon and prove the superiority of OL-HDF over regular hemodialysis regarding the hemodynamic measures.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel, 22100
        • Western Galilee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients affected by IDH during one or more dialytic sessions every week

Exclusion Criteria:

  • Patients with recent change in chronic medications, chronic liver disease, recent acute coronary event, cardiac arrhythmias and acute infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Flux Hemodialysis
Device: NICaS
The NICaS is a non invasive device for measuring and calculating of hemodynamic parameters including mean arterial pressure (mm/Hg), cardiac index (l/min/m2) and total peripheral resistance (dynes/sec/cm5).
EXPERIMENTAL: OL-HDF
Device: NICaS
The NICaS is a non invasive device for measuring and calculating of hemodynamic parameters including mean arterial pressure (mm/Hg), cardiac index (l/min/m2) and total peripheral resistance (dynes/sec/cm5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.
Time Frame: 5 weeks
5 weeks
Mean arterial pressure (mm/Hg)
Time Frame: 5 weeks
5 weeks
Cardiac index (l/min/m2)
Time Frame: 5 weeks
5 weeks
Total peripheral resistance (dynes/sec/cm5)
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

January 30, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (ESTIMATE)

March 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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