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PreventionPhase 4NCT03800264

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

A Phase 4 study testing Bisoprolol in people with Prevention and Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 79 years
Conditions the study is for
Prevention, Atrial Fibrillation, CABG
What is being tested?
Bisoprolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteEgypt
Study dates
2 May 2018to 15 Nov 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • .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.

Who cannot join

  • : 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,
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ramymahrose

    Cairo, 02

Other trials in Egypt

About this study

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.

Read the detailed description

The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams University hospitals during a period of 6 months. The study protocol was approved by "research and ethics committee" of anesthesia and intensive care department, Ain Shams University. Informative consent was obtained from the patients before enrolling in the study.

176 Patients were registered in the study. Patients were randomly allocated by computer-generated random number list into two study groups of 88 patients each, with a range of age between 40 and 79 years old and were undergoing elective on pump CABG operations without concomitant procedures.

Group A:

Patients received 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.

Group B:

Patients received bisoprolol as group (A) in addition hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.

Exclusion criteria for the study included: 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 and chronic obstructive pulmonary disease were not included in the study.

Intraoperative technique:

After sedation with diazepam (10 mg intramuscular), radial arterial catheterization, intravenous catheters, and a central venous catheter were introduced in the operating theater. Hemodynamic parameters; Heart rate monitoring, mean arterial pressure, rectal temperature, central venous pressure and arterial blood gas throughout the process was observed. Anesthesia was started by fentanyl (35 mg / kg) and muscle relaxation was achieved with pancronium (0.1 mg / kg), then endotracheal intubation using ventilation with 100% oxygen. The median incision of the sternum was used for cardiac exposure. The left internal mammary artery was harvested and the saphenous vein was prepared, if necessary. All operations were performed under cardiopulmonary bypass and moderate hypothermia (28-328C) with flow rates of 2.2-2.4 l / m2 and the mean perfusion pressure of 50-85 mm Hg. Heart failure was assisted by initial crystalloid cardioplegia (48C, 15 cc / kg) and heart preservation was assisted with 400 cc cold blood Cardioplegia every 20 minutes. The hot shut was performed shortly before removing the cross clamp. The venous cannula was inserted through the right atrial appendix. The arterial cannula was placed in the ascending aorta.

2.3. Postoperative Monitoring: All patients were continuously monitored at the ICU with electrocardiography (ECG), invasive blood pressure and with finger probe for oxygen saturation within 48 h.

Patients developed atrial fibrillation received treatment according to their condition, if they are haemodynamically unstable electrical cardioversion (synchronized adjusted at 100 joules using biphasic electrical cardiovertor) was applied. If they are haemodynamically stable pharmacological cardioversion (amiodarone 5 mg/kg intravenous over 60 minutes, then 1.2 grams per day by continuous intravenous infusion) was used. (5)

Being tested
Bisoprolol
Keywords
Bisoprolol,, corticosteroid,, atrial fibrillation, cardiac surgery
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BisoprololDrug

    Also called HYDROCORTISONE

    PREVENTIVE DOUBLE BLINDED

Study groups in NCT03800264
Study groupRoleWhat they receive
BISOPROLOLActive comparatorBISOPROLOL 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.
Receives: Drug: Bisoprolol
hydrocortisoneActive comparatorhydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days.
Receives: Drug: Bisoprolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HEART RATE

    atrial fibrillation

    Measured: two days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2019
  2. Study start2 May 2018
  3. Primary completion1 Nov 2018
  4. Study completion15 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
DOUBLE BLINDED RANDOMIZED STUDY
Masking
Single blind
Who is masked
Participant
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03800264
Sponsor's protocol ID
Bisoprolol vs corticosteroi
Status last verified
Jan 2019
First submitted
9 Jan 2019
Last updated
15 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bisoprolol in people with Prevention and Atrial Fibrillation, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HEART RATE (time frame: two days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.

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