NCT03800264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 9, 2019

Last Update Submit

January 11, 2019

Conditions

PreventionAtrial FibrillationCABG

Keywords

Bisoprolol,corticosteroid,atrial fibrillationcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • HEART RATE

    atrial fibrillation

    two days

Study Arms (2)

BISOPROLOL

ACTIVE COMPARATOR

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

hydrocortisone

ACTIVE COMPARATOR

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

Interventions

BisoprololDRUG

PREVENTIVE DOUBLE BLINDED

Also known as: HYDROCORTISONE
BISOPROLOLhydrocortisone

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- .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.

You may not qualify if:

  • : 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramymahrose

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

BisoprololHydrocortisone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
BLINDED
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: DOUBLE BLINDED RANDOMIZED STUDY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

May 2, 2018

Primary Completion

November 1, 2018

Study Completion

November 15, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

EG(1)