Removal of Beta Blocker Drugs by Hemodialysis

Phase 1

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Beta blocker

• Registration Number: NCT03361280
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-02-27
• Primary Completion: 2016-03-10
• Study Completion: 2016-03-10
• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Study First Posted: 2017-12-04
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Atenolol	Beta blocker	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.
Bisoprolol	Beta blocker	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.
Metoprolol	Beta blocker	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.
Carvedilol	Beta blocker	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.

Primary Outcome Measures

Name	Time	Method
Dialytic Clearance	Through study completion, average of one year.	Dialytic clearance calculated by the recovery clearance method

Secondary Outcome Measures

Name	Time	Method
Dialytic Clearance	Through study completion, average of one year.	Dialytic clearance calculated by the arteriovenous difference method