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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03800264

Collaborator

(none)

176

Enrollment

Location

Arms

6.5

Actual Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

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

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

DOUBLE BLINDED RANDOMIZED STUDYDOUBLE 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 :

Nov 1, 2018

Actual Study Completion Date :

Nov 15, 2018

Arms and Interventions

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 Names: 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 Names: HYDROCORTISONE

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 Names:

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 Names:

HYDROCORTISONE

Outcome Measures

Primary Outcome Measures

HEART RATE [two days]
atrial fibrillation

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.