Removal of Beta Blocker Drugs by Hemodialysis

November 27, 2017 updated by: Lawson Health Research Institute

Beta-blocker Dialyzability in Maintenance Hemodialysis Patients

Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol, bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood samples and spent dialysate are collected during dialysis. On separate dialysis sessions, patients received the other study drugs until they have taken each of the four study drugs. Dialytic clearance is calculated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

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:

  • at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.

Exclusion Criteria:

  • gastrointestinal or liver disease, body mass index greater than 40 kg/m2, contraindications for receiving a beta blocker (treatment with contraindicated medications, prior adverse reaction, severe reactive airway disease, hemodynamic instability during dialysis).

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atenolol
Atenolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Drug: Beta blocker
Beta blockers are administered as described in arms.
Experimental: Bisoprolol
Bisoprolol (5 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Drug: Beta blocker
Beta blockers are administered as described in arms.
Experimental: Metoprolol
Metoprolol (50 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Drug: Beta blocker
Beta blockers are administered as described in arms.
Experimental: Carvedilol
Carvedilol (6.25 mg) administered 3 hours prior to a hemodialysis session. Blood samples are collected a multiple times during dialysis and spent dialysate is collected at the end of the dialysis session.
Drug: Beta blocker
Beta blockers are administered as described in arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialytic Clearance
Time Frame: Through study completion, average of one year.
Dialytic clearance calculated by the recovery clearance method
Through study completion, average of one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dialytic Clearance
Time Frame: Through study completion, average of one year.
Dialytic clearance calculated by the arteriovenous difference method
Through study completion, average of one year.

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

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 (Actual)

February 27, 2015

Primary Completion (Actual)

March 10, 2016

Study Completion (Actual)

March 10, 2016

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Plasma concentrations of beta blockers will be shared with other researchers if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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