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Removal of Beta Blocker Drugs by Hemodialysis

NCT ID: NCT03361280

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-27

Study Completion Date

2016-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Keywords

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hemodialysis dialytic clearance pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beta blocker

Intervention Type DRUG

Beta blockers are administered as described in arms.

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.

Group Type EXPERIMENTAL

Beta blocker

Intervention Type DRUG

Beta blockers are administered as described in arms.

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.

Group Type EXPERIMENTAL

Beta blocker

Intervention Type DRUG

Beta blockers are administered as described in arms.

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.

Group Type EXPERIMENTAL

Beta blocker

Intervention Type DRUG

Beta blockers are administered as described in arms.

Interventions

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Beta blocker

Beta blockers are administered as described in arms.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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104909

Identifier Type: -

Identifier Source: org_study_id