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Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03800264
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
RAMY AHMED, Ain Shams University

Brief Summary:

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative complications, including increased risk of stroke, prolonged hospital stay and increased costs.

Objectives: The aim of this study was to find reliable, effective, safe and well tolerated tools for the prevention of AF after on pump coronary artery bypass surgery.

Patients and methods: The study included 176 patients (age range 40 to 79 years) and scheduled for elective on pump CABG operations without concomitant procedures. The patients were divided randomly into two equal groups. Group (A) in which bisoprolol was used for prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each patient, the following data were collected: gender, preoperative diseases, intraoperative cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage, incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection and C - reactive protein levels.


Condition or disease Intervention/treatment Phase
Prevention Atrial Fibrillation CABG Drug: Bisoprolol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: DOUBLE BLINDED RANDOMIZED STUDY
Masking: Single (Participant)
Masking Description: BLINDED
Primary Purpose: Prevention
Official Title: Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery
Actual Study Start Date : May 2, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 15, 2018


Arm Intervention/treatment
Active Comparator: BISOPROLOL
BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days.
Drug: Bisoprolol
PREVENTIVE DOUBLE BLINDED
Other Name: HYDROCORTISONE

Active Comparator: hydrocortisone
hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.
Drug: Bisoprolol
PREVENTIVE DOUBLE BLINDED
Other Name: HYDROCORTISONE




Primary Outcome Measures :
  1. HEART RATE [ Time Frame: two days ]
    atrial fibrillation



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- .176 Patients were registered in the study.

.Range of age between 40 and 79 years old .Undergoing elective on pump CABG operations without concomitant procedures.

Exclusion Criteria:

  • : Patients with preoperative rhythm abnormalities (sick sinus syndrome,

    • atrioventricular conduction abnormalities,
    • history of chronic or intermittent AF),
    • pretreatment with classes I and III antiarrhythmic agents,
    • receiving anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors,
    • thyroid disease,
    • renal or liver disease,
    • peripheral arterial atherosclerotic disease,
    • thrombophlebitis,
    • uncontrolled diabetes mellitus,
    • systemic bacterial or mycotic infection,
    • active tuberculosis,
    • Cushing's syndrome,
    • peptic ulcer,
    • psychotic mental disorder,
    • Herpes Simplex keratitis
    • chronic obstructive pulmonary disease were not included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800264


Locations
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Egypt
Ramymahrose
Cairo, Egypt, 02
Sponsors and Collaborators
Ain Shams University

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Responsible Party: RAMY AHMED, lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03800264     History of Changes
Other Study ID Numbers: Bisoprolol vs corticosteroi
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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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 RAMY AHMED, Ain Shams University:
Bisoprolol,
corticosteroid,
atrial fibrillation
cardiac surgery

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Bisoprolol
Anti-Inflammatory Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action