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Trial record 79 of 116 for:    Atenolol

Removal of Beta Blocker Drugs by Hemodialysis

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ClinicalTrials.gov Identifier: NCT03361280
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Beta blocker Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Beta-blocker Dialyzability in Maintenance Hemodialysis Patients
Actual Study Start Date : February 27, 2015
Actual Primary Completion Date : March 10, 2016
Actual Study Completion Date : March 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.




Primary Outcome Measures :
  1. Dialytic Clearance [ Time Frame: Through study completion, average of one year. ]
    Dialytic clearance calculated by the recovery clearance method


Secondary Outcome Measures :
  1. Dialytic Clearance [ Time Frame: Through study completion, average of one year. ]
    Dialytic clearance calculated by the arteriovenous difference method



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

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).

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03361280     History of Changes
Other Study ID Numbers: 104909
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plasma concentrations of beta blockers will be shared with other researchers if requested.

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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
Keywords provided by Lawson Health Research Institute:
hemodialysis
dialytic clearance
pharmacokinetics
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Bisoprolol
Adrenergic beta-Antagonists
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action